Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT00926367
Status:
COMPLETED
Last Update Posted:
2015-05-20
First Post:
2009-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Two-week Study to Compare the Tolerance and Irritation Potential of Two Combination Topical Gel Acne Medications
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002981', 'term': 'Clindamycin'}, {'id': 'D001585', 'term': 'Benzoyl Peroxide'}, {'id': 'D000068816', 'term': 'Adapalene'}, {'id': 'D005782', 'term': 'Gels'}], 'ancestors': [{'id': 'D008034', 'term': 'Lincomycin'}, {'id': 'D055231', 'term': 'Lincosamides'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '14 days', 'description': 'Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.', 'eventGroups': [{'id': 'EG000', 'title': 'Duac', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide', 'otherNumAtRisk': 25, 'otherNumAffected': 13, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Epiduo', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene', 'otherNumAtRisk': 27, 'otherNumAffected': 13, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Joint stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Seaonal allergies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Menstrual cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Earache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Stitches contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Scratched cornea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0.1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Skin Erythema (Redness)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duac', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide'}, {'id': 'OG001', 'title': 'Epiduo', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.56', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '1.89', 'spread': '1.01', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '2.62', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '2.65', 'spread': '0.94', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '2.90', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '2.52', 'spread': '1.03', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '3.08', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '2.81', 'spread': '1.02', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'categories': [{'measurements': [{'value': '3.17', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '3.13', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '3.07', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '3.08', 'spread': '1.01', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '2.87', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '2.98', 'spread': '1.08', 'groupId': 'OG001'}]}]}, {'title': 'Day 9', 'categories': [{'measurements': [{'value': '2.78', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '3.03', 'spread': '0.99', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '2.89', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '2.94', 'spread': '1.02', 'groupId': 'OG001'}]}]}, {'title': 'Day 13', 'categories': [{'measurements': [{'value': '2.85', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '2.83', 'spread': '1.21', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '2.73', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '2.56', 'spread': '1.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Dunn's Multiple Comparisons Test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'A two-tailed p≤ 0.05 was taken as the level of significance for all comparisons.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1 through Day 14', 'description': 'Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below.\n\nGrade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Skin Moisture and Hydration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duac', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide'}, {'id': 'OG001', 'title': 'Epiduo', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '11.50', 'spread': '3.65', 'groupId': 'OG000'}, {'value': '13.07', 'spread': '5.06', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '11.38', 'spread': '2.49', 'groupId': 'OG000'}, {'value': '15.85', 'spread': '9.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '14.51', 'spread': '3.65', 'groupId': 'OG000'}, {'value': '21.65', 'spread': '8.66', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '13.36', 'spread': '3.33', 'groupId': 'OG000'}, {'value': '19.28', 'spread': '8.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 3, 7, and 14', 'description': 'To assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale. Higher values indicate greater water loss/ lower skin moisture levels.\n\nEvaporative water loss measurements provide an instrumental assessment of skin barrier function(one of the layers of the skin. Damage leads to a disruption of the barrier that is accompanied by elevated water loss rates and affects skin moisture and hydration. Higher values indicate greater water loss.', 'unitOfMeasure': 'TEWL rates (gm/m2/hr)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Skin Dryness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duac', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide'}, {'id': 'OG001', 'title': 'Epiduo', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '0.41', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.57', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '0.32', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '0.46', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '0.55', 'spread': '1.15', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'categories': [{'measurements': [{'value': '0.61', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '1.73', 'spread': '1.76', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '0.69', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '1.85', 'spread': '2.01', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '0.60', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '1.87', 'spread': '2.04', 'groupId': 'OG001'}]}]}, {'title': 'Day 9', 'categories': [{'measurements': [{'value': '0.73', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '2.29', 'spread': '1.99', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '0.56', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '1.49', 'spread': '1.77', 'groupId': 'OG001'}]}]}, {'title': 'Day 13', 'categories': [{'measurements': [{'value': '0.80', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '1.26', 'spread': '1.85', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '0.79', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '1.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A two-tailed p≤ 0.05 was taken as the level of significance for all comparisons.', 'statisticalMethod': "Dunn's Multiple Comparisons Test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1 through Day 14', 'description': 'The amount of dryness on the left and right cheek of each panelist.\n\nThe scale used to evaluate skin dryness is:\n\nGrade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring\n\nExpert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Skin Hydration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duac', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide'}, {'id': 'OG001', 'title': 'Epiduo', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '378.06', 'spread': '131.08', 'groupId': 'OG000'}, {'value': '392.09', 'spread': '162.16', 'groupId': 'OG001'}]}]}, {'title': '4 hrs Post 1st Treatment', 'categories': [{'measurements': [{'value': '323.47', 'spread': '154.30', 'groupId': 'OG000'}, {'value': '415.90', 'spread': '197.57', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '420.97', 'spread': '122.60', 'groupId': 'OG000'}, {'value': '465.25', 'spread': '175.65', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '385.91', 'spread': '156.69', 'groupId': 'OG000'}, {'value': '414.77', 'spread': '154.46', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '401.98', 'spread': '156.08', 'groupId': 'OG000'}, {'value': '418.51', 'spread': '139.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 hrs. post 1st Treatment, Days 3, 7, and 14', 'description': 'The ability of an alternating current to flow through the stratum corneum is an indirect measure of its water content. The value recorded is expressed in microsiemens. Higher values indicate greater levels of skin hydration.\n\nTest results were compared to measurements from the other side of the face, which was not treated instead of referring to a normal range. A normal range does not exist for this measurement. Instead, the non-treated side of the face was used as a control to determine the normal level of skin hydration.', 'unitOfMeasure': 'Microsiemens', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self Assessment of Burning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duac', 'description': 'Patients Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide'}, {'id': 'OG001', 'title': 'Epiduo', 'description': 'Patients Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.36', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'Day 9', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '0.31', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Day 13', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1 through Day 14', 'description': 'The amount of burning on the left and right cheek of each panelist.\n\nThe scale used to evaluate burning is:\n\nScale Description:\n\n(scale: 0 = none to 3 = severe)\n\nSubject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self Assessment of Stinging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duac', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide'}, {'id': 'OG001', 'title': 'Epiduo', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'Day 9', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.54', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': 'Day 13', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.57', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1 through Day 14', 'description': 'The amount of stinging on the left and right cheek of each panelist.\n\nThe scale used to evaluate stinging is:\n\nScale Description:\n\n(scale: 0 = none to 3 = severe)\n\nSubject Self Assessments of stinging were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self Assessment of Dryness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duac', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide'}, {'id': 'OG001', 'title': 'Epiduo', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '0.54', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.40', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.36', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'categories': [{'measurements': [{'value': '0.48', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '0.81', 'spread': '1.02', 'groupId': 'OG001'}]}]}, {'title': 'Day 9', 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '1.01', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '0.69', 'spread': '0.88', 'groupId': 'OG001'}]}]}, {'title': 'Day 13', 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '0.46', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '0.69', 'spread': '1.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1 through Day 14', 'description': 'The amount of dryness on the left and right cheek of each panelist.\n\nThe scale used to evaluate dryness is:\n\nScale Description:\n\n(scale: 0 = none to 3 = severe)\n\nSubject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self Assessment of Texture (Roughness)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duac', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide'}, {'id': 'OG001', 'title': 'Epiduo', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.36', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '0.32', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '0.33', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '0.33', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.56', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 9', 'categories': [{'measurements': [{'value': '0.29', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.46', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '0.29', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.46', 'groupId': 'OG001'}]}]}, {'title': 'Day 13', 'categories': [{'measurements': [{'value': '0.33', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '0.29', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1 through Day 14', 'description': 'The amount of roughness on the left and right cheek of each panelist.\n\nThe scale used to evaluate roughness is:\n\nScale Description:\n\n(scale: 0 = none to 3 = severe)\n\nSubject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self Assessment of Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duac', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide'}, {'id': 'OG001', 'title': 'Epiduo', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'Day 9', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 13', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1 through Day 14', 'description': 'The amount of pain on the left and right cheek of each panelist.\n\nThe scale used to evaluate pain is:\n\nScale Description:\n\n(scale: 0 = none to 3 = severe)\n\nSubject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self Assessment of Crusting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duac', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide'}, {'id': 'OG001', 'title': 'Epiduo', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.38', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'Day 9', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'Day 13', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1 through Day 14', 'description': 'The amount of crusting on the left and right cheek of each panelist.\n\nThe scale used to evaluate crusting is:\n\nScale Description:\n\n(scale: 0 = none to 3 = severe)\n\nSubject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self Assessment of Blistering', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duac', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide'}, {'id': 'OG001', 'title': 'Epiduo', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.38', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 9', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 13', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1 through Day 14', 'description': 'The amount of blistering on the left and right cheek of each panelist.\n\nThe scale used to evaluate blistering is:\n\nScale Description:\n\n(scale: 0 = none to 3 = severe)\n\nSubject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self Assessment of Oiliness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duac', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide'}, {'id': 'OG001', 'title': 'Epiduo', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.40', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'Day 9', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 13', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1 through Day 14', 'description': 'The amount of oiliness on the left and right cheek of each panelist.\n\nThe scale used to evaluate oiliness is:\n\nScale Description:\n\n(scale: 0 = none to 3 = severe)\n\nSubject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Product Acceptability and Preference Questionnaire - How do You Rate the Comfort of the Skin Where You Are Currently Treating With the Study Product?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duac', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide'}, {'id': 'OG001', 'title': 'Epiduo', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene'}], 'classes': [{'categories': [{'measurements': [{'value': '2.38', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '2.23', 'spread': '1.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14', 'description': 'The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How do you rate the comfort of the skin where you are currently treating with the study product?\n\nThe subject replied using the following scale:\n\n1. \\- Very Comfortable\n2. \\- Comfortable\n3. \\- Somewhat Comfortable\n4. \\- Somewhat Uncomfortable\n5. \\- Uncomfortable', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Product Acceptability and Preference Questionnaire - How Compliant Were You With Applying the Study Product Each and Every Day?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duac', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide'}, {'id': 'OG001', 'title': 'Epiduo', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '2.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14', 'description': 'The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How compliant were you with applying the study product each and every day?\n\nThe subject replied using the following scale:\n\n0 - Not Compliant at all (\\<50%)\n\n1. \\- Mostly Compliant (50%-79%)\n2. \\- Very Compliant (80%-100%)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Product Acceptability and Preference Questionnaire - Did You Feel That Your Skin Was Hydrated and Moisturized While You Were on Your Study Product?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duac', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide'}, {'id': 'OG001', 'title': 'Epiduo', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene'}], 'classes': [{'categories': [{'measurements': [{'value': '0.58', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '0.51', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14', 'description': 'The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product?\n\nThe subject replied using the following scale:\n\n1 - Yes 0 - No', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Product Acceptability and Preference Questionnaire - Was the Study Product Easy to Use With Make-up?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duac', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide'}, {'id': 'OG001', 'title': 'Epiduo', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene'}], 'classes': [{'categories': [{'measurements': [{'value': '1.04', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '1.46', 'spread': '1.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14', 'description': 'The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up?\n\nThe subject replied using the following scale:\n\n0 - Not Applicable\n\n1. \\- Very Easy\n2. \\- Easy\n3. \\- Neutral\n4. \\- Difficult\n5. \\- Very Difficult', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Product Acceptability and Preference Questionnaire - What Was Your Overall Satisfaction of the Study Product?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duac', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide'}, {'id': 'OG001', 'title': 'Epiduo', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene'}], 'classes': [{'categories': [{'measurements': [{'value': '2.29', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '2.46', 'spread': '1.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14', 'description': 'The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: What was your overall satisfaction of the study product?\n\nThe subject replied using the following scale:\n\n1. \\- Very Satisfied\n2. \\- Satisfied\n3. \\- Neutral\n4. \\- Unsatisfied\n5. \\- Very Unsatisfied', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Product Acceptability and Preference Questionnaire - How do You Rate the Ease of Application of the Study Product?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duac', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide'}, {'id': 'OG001', 'title': 'Epiduo', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene'}], 'classes': [{'categories': [{'measurements': [{'value': '1.17', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14', 'description': 'The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up?\n\nThe subject replied using the following scale:\n\n0 - Not Applicable\n\n1. \\- Very Easy\n2. \\- Easy\n3. \\- Neutral\n4. \\- Difficult\n5. \\- Very Difficult', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Duac', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide'}, {'id': 'FG001', 'title': 'Epiduo', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Skin Irritation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Clinical research center.', 'preAssignmentDetails': 'Panelists who met the eligibility criteria and were willing to participate in the study were required to undergo a 3-day pre-trial conditioning period where they had to stop the use of all facial products. Panelists were required to use the provided Soap Free Cleanser (SFC) for washing their face and were allowed to apply their normal makeup.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Duac', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide'}, {'id': 'BG001', 'title': 'Epiduo', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-01', 'studyFirstSubmitDate': '2009-06-21', 'resultsFirstSubmitDate': '2010-09-07', 'studyFirstSubmitQcDate': '2009-06-22', 'lastUpdatePostDateStruct': {'date': '2015-05-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-11', 'studyFirstPostDateStruct': {'date': '2009-06-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin Erythema (Redness)', 'timeFrame': 'Baseline, Day 1 through Day 14', 'description': 'Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below.\n\nGrade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion'}, {'measure': 'Skin Dryness', 'timeFrame': 'Baseline, Day 1 through Day 14', 'description': 'The amount of dryness on the left and right cheek of each panelist.\n\nThe scale used to evaluate skin dryness is:\n\nGrade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring\n\nExpert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.'}], 'secondaryOutcomes': [{'measure': 'Skin Moisture and Hydration', 'timeFrame': 'Baseline, Days 3, 7, and 14', 'description': 'To assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale. Higher values indicate greater water loss/ lower skin moisture levels.\n\nEvaporative water loss measurements provide an instrumental assessment of skin barrier function(one of the layers of the skin. Damage leads to a disruption of the barrier that is accompanied by elevated water loss rates and affects skin moisture and hydration. Higher values indicate greater water loss.'}, {'measure': 'Skin Hydration', 'timeFrame': 'Baseline, 4 hrs. post 1st Treatment, Days 3, 7, and 14', 'description': 'The ability of an alternating current to flow through the stratum corneum is an indirect measure of its water content. The value recorded is expressed in microsiemens. Higher values indicate greater levels of skin hydration.\n\nTest results were compared to measurements from the other side of the face, which was not treated instead of referring to a normal range. A normal range does not exist for this measurement. Instead, the non-treated side of the face was used as a control to determine the normal level of skin hydration.'}, {'measure': 'Self Assessment of Burning', 'timeFrame': 'Baseline, Day 1 through Day 14', 'description': 'The amount of burning on the left and right cheek of each panelist.\n\nThe scale used to evaluate burning is:\n\nScale Description:\n\n(scale: 0 = none to 3 = severe)\n\nSubject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.'}, {'measure': 'Self Assessment of Stinging', 'timeFrame': 'Baseline, Day 1 through Day 14', 'description': 'The amount of stinging on the left and right cheek of each panelist.\n\nThe scale used to evaluate stinging is:\n\nScale Description:\n\n(scale: 0 = none to 3 = severe)\n\nSubject Self Assessments of stinging were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.'}, {'measure': 'Self Assessment of Dryness', 'timeFrame': 'Baseline, Day 1 through Day 14', 'description': 'The amount of dryness on the left and right cheek of each panelist.\n\nThe scale used to evaluate dryness is:\n\nScale Description:\n\n(scale: 0 = none to 3 = severe)\n\nSubject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.'}, {'measure': 'Self Assessment of Texture (Roughness)', 'timeFrame': 'Baseline, Day 1 through Day 14', 'description': 'The amount of roughness on the left and right cheek of each panelist.\n\nThe scale used to evaluate roughness is:\n\nScale Description:\n\n(scale: 0 = none to 3 = severe)\n\nSubject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.'}, {'measure': 'Self Assessment of Pain', 'timeFrame': 'Baseline, Day 1 through Day 14', 'description': 'The amount of pain on the left and right cheek of each panelist.\n\nThe scale used to evaluate pain is:\n\nScale Description:\n\n(scale: 0 = none to 3 = severe)\n\nSubject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.'}, {'measure': 'Self Assessment of Crusting', 'timeFrame': 'Baseline, Day 1 through Day 14', 'description': 'The amount of crusting on the left and right cheek of each panelist.\n\nThe scale used to evaluate crusting is:\n\nScale Description:\n\n(scale: 0 = none to 3 = severe)\n\nSubject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.'}, {'measure': 'Self Assessment of Blistering', 'timeFrame': 'Baseline, Day 1 through Day 14', 'description': 'The amount of blistering on the left and right cheek of each panelist.\n\nThe scale used to evaluate blistering is:\n\nScale Description:\n\n(scale: 0 = none to 3 = severe)\n\nSubject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.'}, {'measure': 'Self Assessment of Oiliness', 'timeFrame': 'Baseline, Day 1 through Day 14', 'description': 'The amount of oiliness on the left and right cheek of each panelist.\n\nThe scale used to evaluate oiliness is:\n\nScale Description:\n\n(scale: 0 = none to 3 = severe)\n\nSubject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.'}, {'measure': 'Product Acceptability and Preference Questionnaire - How do You Rate the Comfort of the Skin Where You Are Currently Treating With the Study Product?', 'timeFrame': 'Day 14', 'description': 'The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How do you rate the comfort of the skin where you are currently treating with the study product?\n\nThe subject replied using the following scale:\n\n1. \\- Very Comfortable\n2. \\- Comfortable\n3. \\- Somewhat Comfortable\n4. \\- Somewhat Uncomfortable\n5. \\- Uncomfortable'}, {'measure': 'Product Acceptability and Preference Questionnaire - How Compliant Were You With Applying the Study Product Each and Every Day?', 'timeFrame': 'Day 14', 'description': 'The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How compliant were you with applying the study product each and every day?\n\nThe subject replied using the following scale:\n\n0 - Not Compliant at all (\\<50%)\n\n1. \\- Mostly Compliant (50%-79%)\n2. \\- Very Compliant (80%-100%)'}, {'measure': 'Product Acceptability and Preference Questionnaire - Did You Feel That Your Skin Was Hydrated and Moisturized While You Were on Your Study Product?', 'timeFrame': 'Day 14', 'description': 'The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product?\n\nThe subject replied using the following scale:\n\n1 - Yes 0 - No'}, {'measure': 'Product Acceptability and Preference Questionnaire - Was the Study Product Easy to Use With Make-up?', 'timeFrame': 'Day 14', 'description': 'The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up?\n\nThe subject replied using the following scale:\n\n0 - Not Applicable\n\n1. \\- Very Easy\n2. \\- Easy\n3. \\- Neutral\n4. \\- Difficult\n5. \\- Very Difficult'}, {'measure': 'Product Acceptability and Preference Questionnaire - What Was Your Overall Satisfaction of the Study Product?', 'timeFrame': 'Day 14', 'description': 'The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: What was your overall satisfaction of the study product?\n\nThe subject replied using the following scale:\n\n1. \\- Very Satisfied\n2. \\- Satisfied\n3. \\- Neutral\n4. \\- Unsatisfied\n5. \\- Very Unsatisfied'}, {'measure': 'Product Acceptability and Preference Questionnaire - How do You Rate the Ease of Application of the Study Product?', 'timeFrame': 'Day 14', 'description': 'The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up?\n\nThe subject replied using the following scale:\n\n0 - Not Applicable\n\n1. \\- Very Easy\n2. \\- Easy\n3. \\- Neutral\n4. \\- Difficult\n5. \\- Very Difficult'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acne'], 'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'This is a single-blind (blinded expert grader), randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene gel and the contra lateral side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects will be randomly assigned to each product', 'detailedDescription': 'This is a single-blind (blinded expert grader), parallel group, randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, a topical antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene and the contra lateral side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects will be randomly assigned to each product.\n\nThe subjects will be entered into a 2-week treatment phase. The once-daily applications for the study medication will be supervised at the site, Monday through Friday of each week. Subjects will apply the study product at home on Saturdays and Sundays.\n\nA blinded expert grader will rate comparative product tolerance on each week day (excluding Saturdays and Sundays) during the study before study product is applied.\n\nSubject questionnaires will be completed along with collection of all adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects 18 to 45 years of age or older, able to complete the study and comply with study instructions.\n* Female subjects of childbearing potential must have a negative pregnancy test. Sexually active women of childbearing potential participating in the study must have been using a medically acceptable form of contraception\n* Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed.\n* Is willing to discontinue use of all facial products (other than the cleanser provided and makeup or razor and facial shave product) on the face for the 3 days before their baseline/day 0 visit and use only the provided facial products and their normal makeup or razor and facial shaving product for the duration of the study.\n* Is willing to avoid sunburn, tanning, tanning beds or other excessive sun exposure. Understands that if their skin tone changes significantly during the study it will be necessary to discontinue their participation.\n\nExclusion Criteria:\n\n* Male subjects that have facial beards (mustache and/or goatee is acceptable).\n* Is a Type I diabetic.\n* Has active or chronic skin allergies.\n* Has a history of acute or chronic disease that might interfere with, or increase the risk of study participation.\n* Has participated in other facial studies in the preceding 30 days or other clinical studies in preceding 14 days.\n* Had skin cancer treatment in preceding 12 months.\n* Has damaged skin on facial areas (eg, from sunburn, tattoos, scars).\n* Had any medical procedure (eg, laser resurfacing, chemical peels, plastic surgery) to facial areas in preceding 12 months.\n* Had any cosmetic procedure (eg, microdermabrasion, etc.) to facial areas within 8 weeks of the baseline visit.\n* Live in the same household as currently enrolled subjects.\n* Any other condition or factor the investigator or his duly assigned representative believes may affect the skin response or the interpretation of the test results.'}, 'identificationModule': {'nctId': 'NCT00926367', 'briefTitle': 'Two-week Study to Compare the Tolerance and Irritation Potential of Two Combination Topical Gel Acne Medications', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Two-week Study to Determine and Compare the Tolerance and Irritation Potential of Topical Antibiotic and Benzoyl Peroxide to Benzoyl Peroxide and Adapalene Topical Gel Acne Medications', 'orgStudyIdInfo': {'id': 'C0000-405'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clinidamycin/ Benzoyl Peroxide', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide (BPO).', 'interventionNames': ['Drug: Clindamycin and benzoyl peroxide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Benzoyl peroxide and adapalene', 'description': 'Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide (BPO) and adapalene', 'interventionNames': ['Drug: benzoyl peroxide 2.5% and adapalene 0.1% gel']}], 'interventions': [{'name': 'Clindamycin and benzoyl peroxide', 'type': 'DRUG', 'otherNames': ['Duac® Topical Gel (clindamycin and benzoyl peroxide.'], 'description': 'Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide gel. This contains a topical antibiotic and benzoyl peroxide gel.', 'armGroupLabels': ['Clinidamycin/ Benzoyl Peroxide']}, {'name': 'benzoyl peroxide 2.5% and adapalene 0.1% gel', 'type': 'DRUG', 'otherNames': ['benzoyl peroxide gel and adapalene gel'], 'description': 'Once-daily applications, to the randomized side of the face either left or right,benzoyl peroxide and adapalene gel', 'armGroupLabels': ['Benzoyl peroxide and adapalene']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19008', 'city': 'Broomall', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'cyberDERM', 'geoPoint': {'lat': 39.9815, 'lon': -75.35658}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stiefel, a GSK Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}