Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2025-12-31 @ 3:16 PM
Study NCT ID:
NCT01787461
Status:
COMPLETED
Last Update Posted:
2015-03-18
First Post:
2012-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess the Effects of an Oral Dietary Supplement on Overall Facial Appearance Among Healthy Adult Women With Existing Skin Damage From Sun Exposure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C070172', 'term': 'Imedeen'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.', 'otherNumAtRisk': 95, 'otherNumAffected': 24, 'seriousNumAtRisk': 95, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Imedeen', 'description': 'Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.', 'otherNumAtRisk': 98, 'otherNumAffected': 29, 'seriousNumAtRisk': 98, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 24", 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.'}, {'id': 'OG001', 'title': 'Imedeen', 'description': 'Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.'}], 'classes': [{'title': 'Baseline (n=93,97)', 'categories': [{'measurements': [{'value': '6.04', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '5.81', 'spread': '1.30', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24 (n=92,95)', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.358', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.44', 'groupDescription': 'Change at Week 24: Analysis was performed using an analysis of variance (ANOVA) model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'IGA of overall facial appearance was measured using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (\\<=) 3 signifies Mild; greater than (\\>) 3 to \\<=6 signifies Moderate and \\>6 to \\<=9 signifies Severe.', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (m-ITT) population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time- points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Photographic Assessment Compared to Baseline of the Participants Overall Facial Appearance by Independent Panel Review Committee (IPRC) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.'}, {'id': 'OG001', 'title': 'Imedeen', 'description': 'Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.568', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Gamma Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.037', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.27', 'groupDescription': 'Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for Glogau classification of photoaging and site.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'IPRC assessment was performed in accordance with the Canfield procedures and rated the improvement relative to Baseline. The investigators used an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'm-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.'}, {'id': 'OG001', 'title': 'Imedeen', 'description': 'Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.'}], 'classes': [{'title': 'Baseline (n=93,97)', 'categories': [{'measurements': [{'value': '6.04', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '5.81', 'spread': '1.30', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 (n=92,95)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.797', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.33', 'groupDescription': 'Change at Week 12: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'IGA of overall facial appearance was measured using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (\\<=) 3 signifies Mild; greater than (\\>) 3 to \\<=6 signifies Moderate and \\>6 to \\<=9 signifies Severe.', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'm-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time- points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.'}, {'id': 'OG001', 'title': 'Imedeen', 'description': 'Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.'}], 'classes': [{'title': 'Baseline: Fine L/W Periocular A (n=93,97)', 'categories': [{'measurements': [{'value': '5.95', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '5.79', 'spread': '1.44', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Fine L/W Perioral A (n= 93,97)', 'categories': [{'measurements': [{'value': '4.89', 'spread': '1.78', 'groupId': 'OG000'}, {'value': '4.69', 'spread': '1.65', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Under eye dc or bags(n= 93,97)', 'categories': [{'measurements': [{'value': '5.68', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '5.34', 'spread': '1.44', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: MH (n=93,97)', 'categories': [{'measurements': [{'value': '4.95', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '5.06', 'spread': '1.51', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Sallowness/yellowing (n=93,97)', 'categories': [{'measurements': [{'value': '3.41', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '3.51', 'spread': '1.33', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Roughness/texture (n=93,97)', 'categories': [{'measurements': [{'value': '3.10', 'spread': '1.66', 'groupId': 'OG000'}, {'value': '2.77', 'spread': '1.50', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12: Fine L/W Periocular A(n= 92,95)', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.09', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12: Fine L/W Perioral A(n= 92,95)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.07', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12: Under eye dc or bags (n= 92,95)', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.38', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12: MH (n= 92,95)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.42', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12: Sallowness/yellowing (n= 92,95)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.45', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12: Roughness/texture (n= 92,95)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.45', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24: Fine L/W Periocular A(n= 92,95)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.26', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24: Fine L/W Perioral A(n= 92,95)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.09', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24: Under eye dc or bags (n= 92,95)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.66', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.37', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24: MH (n= 92,95)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.36', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24: Sallowness/yellowing (n= 92,95)', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.45', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24: Roughness/texture (n= 92,95)', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.965', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.30', 'groupDescription': 'Change at Week 12, Fine lines/wrinkles (Periocular area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.674', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.30', 'groupDescription': 'Change at Week 12, Fine lines/wrinkles (Perioral area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.916', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.32', 'groupDescription': 'Change at Week 12, Under eye dark circles or bags: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.915', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.35', 'groupDescription': 'Change at Week 12, Mottled hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.672', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.26', 'groupDescription': 'Change at Week 12, Sallowness/yellowing: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.655', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.43', 'groupDescription': 'Change at Week 12, Roughness/texture: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.561', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.43', 'groupDescription': 'Change at Week 24, Fine lines/wrinkles(Periocular area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.356', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.40', 'groupDescription': 'Change at Week 24, Fine lines/wrinkles(Perioral area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.669', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.43', 'groupDescription': 'Change at Week 24, Under eye dark circles or bags: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.954', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.34', 'groupDescription': 'Change at Week 24, Mottled hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.684', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '0.22', 'groupDescription': 'Change at Week 24, Sallowness/yellowing: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.886', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.30', 'groupDescription': 'Change at Week 24, Roughness/texture: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, 24', 'description': 'Investigator performed the assessment of face (Fine lines/wrinkles (L/W) of the periocular area (A), Fine lines/wrinkles of the perioral area, dark circles (dc) or "bags" under the eye, mottled hyperpigmentation (MH), sallowness/yellowing, roughness/texture) using a numerical severity rating scale of 0 to 9, where 0 to less than or equal to (\\<=) 3 signifies Mild; greater than (\\>) 3 to \\<=6 signifies Moderate and \\>6 to \\<=9 signifies Severe.', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (m-ITT) population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time- points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.'}, {'id': 'OG001', 'title': 'Imedeen', 'description': 'Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.'}], 'classes': [{'title': 'Baseline: Decolletage-Crepyness (n=93,97)', 'categories': [{'measurements': [{'value': '4.65', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '4.56', 'spread': '1.60', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Decolletage-MH (n=93,97)', 'categories': [{'measurements': [{'value': '5.09', 'spread': '1.80', 'groupId': 'OG000'}, {'value': '5.08', 'spread': '1.65', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Back of Hands-Crepyness (n=93,97)', 'categories': [{'measurements': [{'value': '5.37', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '5.19', 'spread': '1.42', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Back of Hands-MH (n=93,97)', 'categories': [{'measurements': [{'value': '3.96', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '3.92', 'spread': '1.69', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12: Decolletage-Crepyness (n=92,95)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.49', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12: Decolletage-MH (n=92,95)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.20', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12:Back of Hands-Crepyness(n=92,95)', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.48', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12: Back of Hands-MH (n=92,95)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.08', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24: Decolletage-Crepyness (n=92,95)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.36', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24: Decolletage-MH (n=92,95)', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.14', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24:Back of Hands-Crepyness(n=92,95)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.45', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24: Back of Hands-MH (n=92,95)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.901', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.37', 'groupDescription': 'Change at Week 12, Decolletage-Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.399', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.47', 'groupDescription': 'Change at Week 12, Decolletage-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.875', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '0.32', 'groupDescription': 'Change at Week 12, Back of Hands-Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.43', 'ciLowerLimit': '0.13', 'ciUpperLimit': '0.73', 'groupDescription': 'Change at Week 12, Back of Hands-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.876', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.38', 'groupDescription': 'Change at Week 24, Decolletage-Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.789', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.38', 'groupDescription': 'Change at Week 24, Decolletage-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.901', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.38', 'groupDescription': 'Change at Week 24, Back of Hands- Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.027', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.72', 'groupDescription': 'Change at Week 24, Back of Hands - Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, 24', 'description': 'Investigator performed the assessment of decolletage and back of hands (crepyness, mottled hyperpigmentation \\[MH\\]) using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (\\<=) 3 signifies Mild; greater than (\\>) 3 to \\<=6 signifies Moderate and \\>6 to \\<=9 signifies Severe.', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (m-ITT) population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time -points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Participants Improvement Assessment of Face at Week 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.'}, {'id': 'OG001', 'title': 'Imedeen', 'description': 'Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.'}], 'classes': [{'title': 'Baseline: OA of facial skin (n=93,97)', 'categories': [{'measurements': [{'value': '5.67', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '5.60', 'spread': '1.62', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Fine L/W (n=93,97)', 'categories': [{'measurements': [{'value': '6.51', 'spread': '2.11', 'groupId': 'OG000'}, {'value': '6.46', 'spread': '1.89', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Under eye dc or bags (n=93,97)', 'categories': [{'measurements': [{'value': '5.80', 'spread': '2.66', 'groupId': 'OG000'}, {'value': '5.82', 'spread': '2.64', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Discoloration (n=93,97)', 'categories': [{'measurements': [{'value': '5.85', 'spread': '2.42', 'groupId': 'OG000'}, {'value': '6.59', 'spread': '2.23', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Complexion/Glow (n=93,97)', 'categories': [{'measurements': [{'value': '5.19', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '5.02', 'spread': '1.75', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Smoothness (n=93,97)', 'categories': [{'measurements': [{'value': '6.69', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '6.49', 'spread': '1.86', 'groupId': 'OG001'}]}]}, {'title': 'Improvement Week 12: OA of facial skin (n=92,96)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': 'Improvement Week 12: Fine L/W (n=92,96)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'Improvement Week 12: Under eye dc or bags(n=92,96)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.95', 'groupId': 'OG001'}]}]}, {'title': 'Improvement Week 12: Discoloration (n=91,95)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.01', 'groupId': 'OG001'}]}]}, {'title': 'Improvement Week 12: Complexion/Glow (n=92,96)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.86', 'groupId': 'OG001'}]}]}, {'title': 'Improvement Week 12: Smoothness (n=92,96)', 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.97', 'groupId': 'OG001'}]}]}, {'title': 'Improvement Week 24: OA of facial skin (n=92,96)', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.26', 'groupId': 'OG001'}]}]}, {'title': 'Improvement Week 24: Fine L/W (n=92,96)', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.18', 'groupId': 'OG001'}]}]}, {'title': 'Improvement Week 24: Under eye dc or bags(n=92,96)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.08', 'groupId': 'OG001'}]}]}, {'title': 'Improvement Week 24: Discoloration (n=91,93)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.11', 'groupId': 'OG001'}]}]}, {'title': 'Improvement Week 24: Complexion/Glow (n=92,96)', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.12', 'groupId': 'OG001'}]}]}, {'title': 'Improvement Week 24: Smoothness (n=92,96)', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.688', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Gamma Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.083', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.27', 'groupDescription': 'Improvement Week 12, Overall appearance of facial skin: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.445', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Gamma Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.121', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.33', 'groupDescription': 'Improvement Week 12, Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.318', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Gamma Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.205', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.40', 'groupDescription': 'Improvement Week 12, Under eye dark circles or bags: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.633', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Gamma Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.012', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.12', 'groupDescription': 'Improvement Week 12, Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.996', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Gamma Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.018', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.19', 'groupDescription': 'Improvement Week 12, Complexion/Glow: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.432', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Gamma Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.059', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.25', 'groupDescription': 'Improvement Week 12, Smoothness: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.833', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Gamma Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.030', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.19', 'groupDescription': 'Improvement Week 24, Overall appearance of facial skin: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.171', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Gamma Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.226', 'ciLowerLimit': '0.06', 'ciUpperLimit': '0.39', 'groupDescription': 'Improvement Week 24, Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.796', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Gamma Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.020', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.12', 'groupDescription': 'Improvement Week 24, Under eye dark circles or bags: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.942', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Gamma Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.033', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.16', 'groupDescription': 'Improvement Week 24, Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.405', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Gamma Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.118', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.28', 'groupDescription': 'Improvement Week 24, Complexion/Glow: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.687', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Gamma Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.061', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.26', 'groupDescription': 'Improvement Week 24, Smoothness: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, 24', 'description': 'Participants performed the assessment of face (overall facial (OA) appearance, fine lines and wrinkles (L/W) present in the eye area, upper lip, or cheek areas, under eye dark circles (dc) or bags, discoloration \\[uneven, patchy, blotchy areas of light and dark, age spots, liver spots\\], complexion/glow \\[bright radiant appearance\\] and smoothness) at Baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the facial parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'm-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time- points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.'}, {'id': 'OG001', 'title': 'Imedeen', 'description': 'Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.'}], 'classes': [{'title': 'Baseline: Decolletage-Overall (n=93,97)', 'categories': [{'measurements': [{'value': '5.34', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '5.19', 'spread': '1.92', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Decolletage-W/C (n=93,97)', 'categories': [{'measurements': [{'value': '5.59', 'spread': '2.35', 'groupId': 'OG000'}, {'value': '5.48', 'spread': '2.22', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Decolletage-Discoloration (n=93,97)', 'categories': [{'measurements': [{'value': '5.88', 'spread': '2.59', 'groupId': 'OG000'}, {'value': '6.06', 'spread': '2.21', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Back of Hands-Overall (n=93,97)', 'categories': [{'measurements': [{'value': '4.89', 'spread': '2.15', 'groupId': 'OG000'}, {'value': '4.89', 'spread': '1.98', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Back of Hands - Fine L/W (n=93,97)', 'categories': [{'measurements': [{'value': '6.23', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '6.53', 'spread': '2.25', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Back of Hands - Discoloration (n=93,97)', 'categories': [{'measurements': [{'value': '5.91', 'spread': '2.62', 'groupId': 'OG000'}, {'value': '5.83', 'spread': '2.56', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Body - Dryness Overall (n=93,97)', 'categories': [{'measurements': [{'value': '5.34', 'spread': '2.23', 'groupId': 'OG000'}, {'value': '5.15', 'spread': '2.03', 'groupId': 'OG001'}]}]}, {'title': 'Improvement Week 12: Decolletage-Overall (n=92,96)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'Improvement Week 12: Decolletage-W/C (n=92,96)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Improvement Week 12: DD (n=87,94)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'Improvement Week 12: BOH-Overall (n=92,96)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': 'Improvement Week 12: BOH - Fine L/W (n=92,96)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'Improvement Week 12: BOH - Discoloration (n=88,94)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'Improvement Week 12: BD Overall (n=91,96)', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.06', 'groupId': 'OG001'}]}]}, {'title': 'Improvement Week 24: Decolletage-Overall (n=92,96)', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.03', 'groupId': 'OG001'}]}]}, {'title': 'Improvement Week 24: Decolletage-W/C (n=92,96)', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.98', 'groupId': 'OG001'}]}]}, {'title': 'Improvement Week 24: DD (n=88,91)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.08', 'groupId': 'OG001'}]}]}, {'title': 'Improvement Week 24:BOH-Overall (n=92,96)', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.08', 'groupId': 'OG001'}]}]}, {'title': 'Improvement Week 24: BOH - Fine L/W (n=92,96)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.02', 'groupId': 'OG001'}]}]}, {'title': 'Improvement Week 24: BOH - Discoloration (n=91,91)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.97', 'groupId': 'OG001'}]}]}, {'title': 'Improvement Week 24: BD Overall (n=92,96)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.017', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Gamma Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.384', 'ciLowerLimit': '0.23', 'ciUpperLimit': '0.54', 'groupDescription': 'Improvement Week 12, Decolletage-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.073', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Gamma Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.248', 'ciLowerLimit': '0.09', 'ciUpperLimit': '0.40', 'groupDescription': 'Improvement Week 12, Decolletage-Wrinkling/crinkling: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.117', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Gamma Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.057', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.22', 'groupDescription': 'Improvement Week 12, Decolletage-Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.662', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Gamma Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.096', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.12', 'groupDescription': 'Improvement Week 12, Back of Hands-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.373', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Gamma Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.100', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.25', 'groupDescription': 'Improvement Week 12, Back of Hands - Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.294', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Gamma Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.031', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.12', 'groupDescription': 'Improvement Week 12, Back of Hands - Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.857', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Gamma Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.035', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.13', 'groupDescription': 'Improvement Week 12, Body - Dryness Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.088', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Gamma Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.206', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.39', 'groupDescription': 'Improvement Week 24, Decolletage-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.110', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Gamma Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.193', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.41', 'groupDescription': 'Improvement Week 24, Decolletage-Wrinkling/crinkling: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.112', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Gamma Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.205', 'ciLowerLimit': '0.07', 'ciUpperLimit': '0.34', 'groupDescription': 'Improvement Week 24, Decolletage-Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.614', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Gamma Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.003', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.13', 'groupDescription': 'Improvement Week 24, Back of Hands-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.693', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Gamma Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.011', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.16', 'groupDescription': 'Improvement Week 24, Back of Hands - Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.762', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Gamma Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.079', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.22', 'groupDescription': 'Improvement Week 24, Back of Hands - Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.662', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Gamma Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.013', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.13', 'groupDescription': 'Improvement Week 24, Body - Dryness Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, 24', 'description': 'Participants performed the assessment of decolletage (decolletage overall, decolletage-wrinkling/crinkling (W/C), decolletage-discoloration (DD) and back of hands (back of hands overall, back of hands (BOH) - Fine lines/wrinkles (L/W), back of hands - discoloration) and Body - Dryness (BD) Overall at baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the Decolletage, Back of Hands and Body parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'm-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time- points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.'}, {'id': 'OG001', 'title': 'Imedeen', 'description': 'Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.'}], 'classes': [{'title': 'Baseline: Left Cheek (n=93,97)', 'categories': [{'measurements': [{'value': '231.7', 'spread': '54.58', 'groupId': 'OG000'}, {'value': '238.7', 'spread': '69.69', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6: Left Cheek (n=93,97)', 'categories': [{'measurements': [{'value': '-5.2', 'spread': '48.13', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '70.39', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12: Left Cheek (n=87,92)', 'categories': [{'measurements': [{'value': '16.7', 'spread': '52.70', 'groupId': 'OG000'}, {'value': '20.0', 'spread': '69.01', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 18: Left Cheek (n=85,91)', 'categories': [{'measurements': [{'value': '35.1', 'spread': '47.03', 'groupId': 'OG000'}, {'value': '35.5', 'spread': '70.18', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24: Left Cheek (n=85,91)', 'categories': [{'measurements': [{'value': '33.1', 'spread': '53.86', 'groupId': 'OG000'}, {'value': '29.1', 'spread': '71.44', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Left Inner Arm (n=93,97)', 'categories': [{'measurements': [{'value': '150.0', 'spread': '41.37', 'groupId': 'OG000'}, {'value': '157.2', 'spread': '52.72', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6: Left Inner Arm (n=93,97)', 'categories': [{'measurements': [{'value': '-10.6', 'spread': '48.51', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '54.36', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12: Left Inner Arm (n=87,92)', 'categories': [{'measurements': [{'value': '-5.2', 'spread': '69.84', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '61.24', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 18: Left Inner Arm (n=85,91)', 'categories': [{'measurements': [{'value': '15.3', 'spread': '45.69', 'groupId': 'OG000'}, {'value': '15.7', 'spread': '55.30', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24: Left Inner Arm (n=85,91)', 'categories': [{'measurements': [{'value': '15.4', 'spread': '39.36', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '53.89', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Left Outer Arm (n=93,97)', 'categories': [{'measurements': [{'value': '120.0', 'spread': '49.37', 'groupId': 'OG000'}, {'value': '130.0', 'spread': '61.83', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6: Left Outer Arm (n=93,97)', 'categories': [{'measurements': [{'value': '-6.4', 'spread': '42.13', 'groupId': 'OG000'}, {'value': '-3.5', 'spread': '57.26', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12: Left Outer Arm (n=87,92)', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '45.13', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '57.49', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 18: Left Outer Arm (n=85,91)', 'categories': [{'measurements': [{'value': '9.8', 'spread': '45.27', 'groupId': 'OG000'}, {'value': '14.0', 'spread': '58.47', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24: Left Outer Arm (n=85,91)', 'categories': [{'measurements': [{'value': '9.4', 'spread': '48.60', 'groupId': 'OG000'}, {'value': '10.2', 'spread': '50.92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.587', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.93', 'ciLowerLimit': '-10.32', 'ciUpperLimit': '18.18', 'groupDescription': 'Change at Week 6, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.814', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.08', 'ciLowerLimit': '-14.49', 'ciUpperLimit': '12.32', 'groupDescription': 'Change at Week 12, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.453', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.57', 'ciLowerLimit': '-16.14', 'ciUpperLimit': '8.99', 'groupDescription': 'Change at Week 18, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.191', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.16', 'ciLowerLimit': '-22.92', 'ciUpperLimit': '4.61', 'groupDescription': 'Change at Week 24, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.685', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.61', 'ciLowerLimit': '-10.07', 'ciUpperLimit': '15.28', 'groupDescription': 'Change at Week 6, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.480', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.74', 'ciLowerLimit': '-11.67', 'ciUpperLimit': '23.15', 'groupDescription': 'Change at Week 12, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.299', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.98', 'ciLowerLimit': '-17.29', 'ciUpperLimit': '5.34', 'groupDescription': 'Change at Week 18, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.107', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.07', 'ciLowerLimit': '-20.04', 'ciUpperLimit': '1.90', 'groupDescription': 'Change at Week 24, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.776', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.82', 'ciLowerLimit': '-14.39', 'ciUpperLimit': '10.76', 'groupDescription': 'Change at Week 6, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.603', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.33', 'ciLowerLimit': '-15.96', 'ciUpperLimit': '9.29', 'groupDescription': 'Change at Week 12, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.510', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.82', 'ciLowerLimit': '-15.23', 'ciUpperLimit': '7.60', 'groupDescription': 'Change at Week 18, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.225', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.75', 'ciLowerLimit': '-17.70', 'ciUpperLimit': '4.20', 'groupDescription': 'Change at Week 24, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6, 12, 18, 24', 'description': 'DermaLab Combo Skin Lab with an 8-pin probe was used to measure hydration (corneometry). Hydration measurements of the left cheek, left inner arm, and left outer arm were taken (up to 3 measurement).', 'unitOfMeasure': 'microsecond', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'm-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time- points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.'}, {'id': 'OG001', 'title': 'Imedeen', 'description': 'Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.'}], 'classes': [{'title': 'Baseline: Left Cheek (n=93,97)', 'categories': [{'measurements': [{'value': '11.7', 'spread': '5.27', 'groupId': 'OG000'}, {'value': '11.0', 'spread': '5.04', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6: Left Cheek (n=93,97)', 'categories': [{'measurements': [{'value': '-0.0', 'spread': '5.21', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '4.34', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12: Left Cheek (n=87,92)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '3.72', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '4.71', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 18: Left Cheek (n=85,91)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '3.84', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '4.35', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24: Left Cheek (n=85,91)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '4.15', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '4.29', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Left Inner Arm (n=93,97)', 'categories': [{'measurements': [{'value': '4.8', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '1.90', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6: Left Inner Arm (n=93,97)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '2.46', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12: Left Inner Arm (n=87,92)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.67', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 18: Left Inner Arm (n=85,91)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.80', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24: Left Inner Arm (n=85,91)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.72', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Left Outer Arm (n=93,97)', 'categories': [{'measurements': [{'value': '4.6', 'spread': '1.98', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '1.57', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6: Left Outer Arm (n=93,97)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.81', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12: Left Outer Arm (n=87,92)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.67', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 18: Left Outer Arm (n=85,91)', 'categories': [{'measurements': [{'value': '-0.0', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.72', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24: Left Outer Arm (n=85,91)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.64', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '1.49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.214', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '2.02', 'groupDescription': 'Change at Week 6, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.027', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.12', 'ciUpperLimit': '2.09', 'groupDescription': 'Change at Week 12, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.049', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.01', 'ciUpperLimit': '1.96', 'groupDescription': 'Change at Week 18, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.20', 'ciUpperLimit': '2.14', 'groupDescription': 'Change at Week 24, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.449', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '0.80', 'groupDescription': 'Change at Week 6, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.105', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.37', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.80', 'groupDescription': 'Change at Week 12, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.205', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.68', 'groupDescription': 'Change at Week 18, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.100', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.35', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.77', 'groupDescription': 'Change at Week 24, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.244', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.66', 'groupDescription': 'Change at Week 6, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.594', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.56', 'groupDescription': 'Change at Week 12, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.317', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.63', 'groupDescription': 'Change at Week 18, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.264', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.64', 'groupDescription': 'Change at Week 24, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6, 12, 18, 24', 'description': 'Trans-epidermal water loss (TEWL) measurements were done using DermaLab Combo SkinLab with a cylindrical diffusion chamber (10 mm \\[millimeter\\] diameter) containing 2 combined humidity/temperature sensors to determine the amount of water vapor that moves across the stratum corneum. TEWL measurements were taken on the left cheek and the left inner and outer arm (up to 3 measurement).', 'unitOfMeasure': 'gram per square meter per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'm-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time- points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Skin Thickness at Week 6, 12,18 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.'}, {'id': 'OG001', 'title': 'Imedeen', 'description': 'Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.'}], 'classes': [{'title': 'Baseline: Left Cheek (n=93,97)', 'categories': [{'measurements': [{'value': '1568.2', 'spread': '234.01', 'groupId': 'OG000'}, {'value': '1531.1', 'spread': '243.04', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6: Left Cheek (n=89,95)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '169.50', 'groupId': 'OG000'}, {'value': '-33.9', 'spread': '164.03', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12: Left Cheek (n=87,92)', 'categories': [{'measurements': [{'value': '11.3', 'spread': '167.01', 'groupId': 'OG000'}, {'value': '-37.1', 'spread': '169.86', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 18: Left Cheek (n=84,90)', 'categories': [{'measurements': [{'value': '-21.7', 'spread': '173.71', 'groupId': 'OG000'}, {'value': '-45.8', 'spread': '169.60', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24: Left Cheek (n=82,90)', 'categories': [{'measurements': [{'value': '-55.6', 'spread': '225.02', 'groupId': 'OG000'}, {'value': '-81.1', 'spread': '230.14', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Left Inner Arm (n=93,96)', 'categories': [{'measurements': [{'value': '1101.8', 'spread': '159.25', 'groupId': 'OG000'}, {'value': '1076.4', 'spread': '137.32', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6: Left Inner Arm (n=91,96)', 'categories': [{'measurements': [{'value': '4.7', 'spread': '94.41', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '86.69', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12: Left Inner Arm (n=87,91)', 'categories': [{'measurements': [{'value': '-11.1', 'spread': '102.32', 'groupId': 'OG000'}, {'value': '-15.6', 'spread': '92.83', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 18: Left Inner Arm (n=84,88)', 'categories': [{'measurements': [{'value': '-16.6', 'spread': '117.88', 'groupId': 'OG000'}, {'value': '-43.2', 'spread': '108.18', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24: Left Inner Arm (n=82,89)', 'categories': [{'measurements': [{'value': '-73.2', 'spread': '126.50', 'groupId': 'OG000'}, {'value': '-66.6', 'spread': '126.87', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Left Outer Arm (n=93,96)', 'categories': [{'measurements': [{'value': '1349.4', 'spread': '191.23', 'groupId': 'OG000'}, {'value': '1332.2', 'spread': '169.61', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6: Left Outer Arm (n=92,96)', 'categories': [{'measurements': [{'value': '9.1', 'spread': '106.38', 'groupId': 'OG000'}, {'value': '17.0', 'spread': '100.85', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12: Left Outer Arm (n=87,91)', 'categories': [{'measurements': [{'value': '9.5', 'spread': '101.58', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '95.81', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 18: Left Outer Arm (n=84,89)', 'categories': [{'measurements': [{'value': '-3.3', 'spread': '117.71', 'groupId': 'OG000'}, {'value': '-23.1', 'spread': '120.42', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24: Left Outer Arm (n=82,89)', 'categories': [{'measurements': [{'value': '-55.3', 'spread': '144.09', 'groupId': 'OG000'}, {'value': '-55.3', 'spread': '135.32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.266', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.16', 'ciLowerLimit': '-69.63', 'ciUpperLimit': '19.31', 'groupDescription': 'Change at Week 6, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.210', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-28.79', 'ciLowerLimit': '-73.99', 'ciUpperLimit': '16.41', 'groupDescription': 'Change at Week 12, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.753', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.78', 'ciLowerLimit': '-56.55', 'ciUpperLimit': '40.99', 'groupDescription': 'Change at Week 18, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.632', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.90', 'ciLowerLimit': '-76.32', 'ciUpperLimit': '46.51', 'groupDescription': 'Change at Week 24, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.715', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.54', 'ciLowerLimit': '-19.94', 'ciUpperLimit': '29.01', 'groupDescription': 'Change at Week 6, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.648', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.35', 'ciLowerLimit': '-21.04', 'ciUpperLimit': '33.75', 'groupDescription': 'Change at Week 12, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.315', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.49', 'ciLowerLimit': '-48.81', 'ciUpperLimit': '15.83', 'groupDescription': 'Change at Week 18, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.402', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.42', 'ciLowerLimit': '-19.50', 'ciUpperLimit': '48.34', 'groupDescription': 'Change at Week 24, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.381', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.43', 'ciLowerLimit': '-15.49', 'ciUpperLimit': '40.35', 'groupDescription': 'Change at Week 6, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.916', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.49', 'ciLowerLimit': '-26.44', 'ciUpperLimit': '29.43', 'groupDescription': 'Change at Week 12, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.566', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.88', 'ciLowerLimit': '-43.81', 'ciUpperLimit': '24.05', 'groupDescription': 'Change at Week 18, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.667', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.58', 'ciLowerLimit': '-30.78', 'ciUpperLimit': '47.94', 'groupDescription': 'Change at Week 24, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6, 12, 18, 24', 'description': 'Skin thickness was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement).', 'unitOfMeasure': 'micrometer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'm-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time -points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.'}, {'id': 'OG001', 'title': 'Imedeen', 'description': 'Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.'}], 'classes': [{'title': 'Baseline: Left Cheek (n=58,59)', 'categories': [{'measurements': [{'value': '10.5', 'spread': '4.05', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '3.78', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6: Left Cheek (n=57,59)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '4.43', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '5.13', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12: Left Cheek (n=54,55)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '4.49', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '4.34', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 18: Left Cheek (n=49,52)', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '5.68', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '6.22', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24: Left Cheek (n=49,53)', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '5.68', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '5.42', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Left Inner Arm (n=58,58)', 'categories': [{'measurements': [{'value': '28.0', 'spread': '6.96', 'groupId': 'OG000'}, {'value': '29.2', 'spread': '8.41', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6: Left Inner Arm (n=57,58)', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '10.20', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '11.61', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12: Left Inner Arm (n=54,54)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '8.73', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '10.05', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 18: Left Inner Arm (n=49,50)', 'categories': [{'measurements': [{'value': '-4.5', 'spread': '10.73', 'groupId': 'OG000'}, {'value': '-4.6', 'spread': '13.87', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24: Left Inner Arm (n=49,52)', 'categories': [{'measurements': [{'value': '-6.6', 'spread': '10.98', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': '11.64', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Left Outer Arm (n=58,58)', 'categories': [{'measurements': [{'value': '19.5', 'spread': '5.82', 'groupId': 'OG000'}, {'value': '19.4', 'spread': '6.66', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6: Left Outer Arm (n=58,58)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '7.47', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '7.75', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12: Left Outer Arm (n=54,54)', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '6.61', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '7.93', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 18: Left Outer Arm (n=49,51)', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '9.01', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '10.10', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24: Left Outer Arm (n=49,52)', 'categories': [{'measurements': [{'value': '-4.5', 'spread': '9.45', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '9.69', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.458', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.60', 'ciLowerLimit': '-2.21', 'ciUpperLimit': '1.00', 'groupDescription': 'Change at Week 6, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.497', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.53', 'ciLowerLimit': '-2.07', 'ciUpperLimit': '1.01', 'groupDescription': 'Change at Week 12, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.113', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.36', 'ciLowerLimit': '-3.05', 'ciUpperLimit': '0.33', 'groupDescription': 'Change at Week 18, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.708', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-2.11', 'ciUpperLimit': '1.44', 'groupDescription': 'Change at Week 24, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.495', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.24', 'ciLowerLimit': '-2.34', 'ciUpperLimit': '4.82', 'groupDescription': 'Change at Week 6, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.243', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.85', 'ciLowerLimit': '-4.96', 'ciUpperLimit': '1.27', 'groupDescription': 'Change at Week 12, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.453', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.36', 'ciLowerLimit': '-4.96', 'ciUpperLimit': '2.23', 'groupDescription': 'Change at Week 18, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.745', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '-2.79', 'ciUpperLimit': '3.89', 'groupDescription': 'Change at Week 24, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.987', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-2.44', 'ciUpperLimit': '2.48', 'groupDescription': 'Change at Week 6, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.218', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.42', 'ciLowerLimit': '-3.69', 'ciUpperLimit': '0.85', 'groupDescription': 'Change at Week 12, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.630', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.67', 'ciLowerLimit': '-3.41', 'ciUpperLimit': '2.08', 'groupDescription': 'Change at Week 18, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.576', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '-2.06', 'ciUpperLimit': '3.68', 'groupDescription': 'Change at Week 24, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6, 12, 18, 24', 'description': 'Skin density was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system with 100 percent (%) calibration mode. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement).', 'unitOfMeasure': 'micrometer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'm-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time- points for each arm, respectively.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.'}, {'id': 'FG001', 'title': 'Imedeen', 'description': 'Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '89'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'No longer met eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.'}, {'id': 'BG001', 'title': 'Imedeen', 'description': 'Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.5', 'spread': '7.38', 'groupId': 'BG000'}, {'value': '52.7', 'spread': '6.58', 'groupId': 'BG001'}, {'value': '52.6', 'spread': '6.96', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety analysis set included all participants who received at least one dose of the study treatments.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 194}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-05', 'studyFirstSubmitDate': '2012-12-05', 'resultsFirstSubmitDate': '2015-03-05', 'studyFirstSubmitQcDate': '2013-02-06', 'lastUpdatePostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-03-05', 'studyFirstPostDateStruct': {'date': '2013-02-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 24", 'timeFrame': 'Baseline, Week 24', 'description': 'IGA of overall facial appearance was measured using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (\\<=) 3 signifies Mild; greater than (\\>) 3 to \\<=6 signifies Moderate and \\>6 to \\<=9 signifies Severe.'}], 'secondaryOutcomes': [{'measure': 'Photographic Assessment Compared to Baseline of the Participants Overall Facial Appearance by Independent Panel Review Committee (IPRC) at Week 24', 'timeFrame': 'Week 24', 'description': 'IPRC assessment was performed in accordance with the Canfield procedures and rated the improvement relative to Baseline. The investigators used an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).'}, {'measure': "Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 12", 'timeFrame': 'Baseline, Week 12', 'description': 'IGA of overall facial appearance was measured using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (\\<=) 3 signifies Mild; greater than (\\>) 3 to \\<=6 signifies Moderate and \\>6 to \\<=9 signifies Severe.'}, {'measure': 'Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24', 'timeFrame': 'Baseline, Week 12, 24', 'description': 'Investigator performed the assessment of face (Fine lines/wrinkles (L/W) of the periocular area (A), Fine lines/wrinkles of the perioral area, dark circles (dc) or "bags" under the eye, mottled hyperpigmentation (MH), sallowness/yellowing, roughness/texture) using a numerical severity rating scale of 0 to 9, where 0 to less than or equal to (\\<=) 3 signifies Mild; greater than (\\>) 3 to \\<=6 signifies Moderate and \\>6 to \\<=9 signifies Severe.'}, {'measure': 'Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24', 'timeFrame': 'Baseline, Week 12, 24', 'description': 'Investigator performed the assessment of decolletage and back of hands (crepyness, mottled hyperpigmentation \\[MH\\]) using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (\\<=) 3 signifies Mild; greater than (\\>) 3 to \\<=6 signifies Moderate and \\>6 to \\<=9 signifies Severe.'}, {'measure': 'Participants Improvement Assessment of Face at Week 12 and 24', 'timeFrame': 'Baseline, Week 12, 24', 'description': 'Participants performed the assessment of face (overall facial (OA) appearance, fine lines and wrinkles (L/W) present in the eye area, upper lip, or cheek areas, under eye dark circles (dc) or bags, discoloration \\[uneven, patchy, blotchy areas of light and dark, age spots, liver spots\\], complexion/glow \\[bright radiant appearance\\] and smoothness) at Baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the facial parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).'}, {'measure': 'Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24', 'timeFrame': 'Baseline, Week 12, 24', 'description': 'Participants performed the assessment of decolletage (decolletage overall, decolletage-wrinkling/crinkling (W/C), decolletage-discoloration (DD) and back of hands (back of hands overall, back of hands (BOH) - Fine lines/wrinkles (L/W), back of hands - discoloration) and Body - Dryness (BD) Overall at baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the Decolletage, Back of Hands and Body parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).'}, {'measure': 'Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24', 'timeFrame': 'Baseline, Week 6, 12, 18, 24', 'description': 'DermaLab Combo Skin Lab with an 8-pin probe was used to measure hydration (corneometry). Hydration measurements of the left cheek, left inner arm, and left outer arm were taken (up to 3 measurement).'}, {'measure': 'Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24', 'timeFrame': 'Baseline, Week 6, 12, 18, 24', 'description': 'Trans-epidermal water loss (TEWL) measurements were done using DermaLab Combo SkinLab with a cylindrical diffusion chamber (10 mm \\[millimeter\\] diameter) containing 2 combined humidity/temperature sensors to determine the amount of water vapor that moves across the stratum corneum. TEWL measurements were taken on the left cheek and the left inner and outer arm (up to 3 measurement).'}, {'measure': 'Change From Baseline in Skin Thickness at Week 6, 12,18 and 24', 'timeFrame': 'Baseline, Week 6, 12, 18, 24', 'description': 'Skin thickness was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement).'}, {'measure': 'Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode)', 'timeFrame': 'Baseline, Week 6, 12, 18, 24', 'description': 'Skin density was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system with 100 percent (%) calibration mode. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Trial assessing effects of an oral dietary supplement on overall facial appearance among healthy women with photodamaged skin.'], 'conditions': ['Photodamaged Skin']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B5271003&StudyName=A%20study%20to%20assess%20the%20effects%20of%20an%20oral%20dietary%20supplement%20on%20overall%20facial%20appearance%20among%20healthy%20adult%20women%20with%20existing%20ski', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The study hypothesis is that Imedeen will show effects on skin health, when compared to placebo over a 6 month intervention period with respect to changes in skin appearance, skin density, moisture, and in fine lines and wrinkles.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIn general good health and have no contraindications to the study product; Have Fitzpatrick Skin Type I-IV as determined by a trained evaluator. Have Glogau Classification of Photoaging of II or III as determined by the investigator.\n\nExclusion Criteria:\n\nUse of any dietary supplement, over-the-counter or prescription product with the indication of improving the appearance or condition of the skin within one month of baseline.\n\nHistory of or current disease or condition of the skin that the investigator deems inappropriate for participation (eg, atopic skin, facial scars, psoriasis, eczema, other scaly inflammatory diseases).\n\nSubjects who have had a facial cosmetic procedures (eg, fillers, toxins, facial peel) or invasive surgical procedures (eg, laser treatment or face lift) or other facial treatments by a physician or skin care professional within the last 6 to 9 months from baseline (pending procedure type) or plan to have a treatment during the study.'}, 'identificationModule': {'nctId': 'NCT01787461', 'briefTitle': 'A Study to Assess the Effects of an Oral Dietary Supplement on Overall Facial Appearance Among Healthy Adult Women With Existing Skin Damage From Sun Exposure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Randomized, Double-blind, Placebo Controlled Trial Assessing The Effects Of An Oral Dietary Supplement Containing Marine And Plant Extracts On Overall Facial Skin Appearance Among Healthy Adult Women With Photo-aged Skin', 'orgStudyIdInfo': {'id': 'B5271003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Imedeen', 'description': 'Imedeen is the study product', 'interventionNames': ['Dietary Supplement: Imedeen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Imedeen', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Imedeen Time Perfection'], 'description': 'Two tablets per day for 6 months', 'armGroupLabels': ['Imedeen']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Two tablets per day for 6 months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33137', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baumann Cosmetic and Research Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '07410', 'city': 'Fair Lawn', 'state': 'New Jersey', 'country': 'United States', 'facility': 'TKL Research, Inc.', 'geoPoint': {'lat': 40.94038, 'lon': -74.13181}}, {'zip': '24501', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'The Education & Research Foundation, Inc.', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}, {'zip': '23462', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'McDaniel Institute of Anti-Aging Research', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}