Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-28 @ 6:47 PM
Study NCT ID:
NCT01205061
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2010-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Emervel® Deep Lidocaine vs. Juvederm® Ultra Plus in Treatment of Moderate to Severe Facial Wrinkles and Folds
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'reception.seupp@galderma.com', 'phone': '+46184749000', 'title': 'Clinical Scientist', 'organization': 'Galderma'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of study drug administration up to 62 weeks', 'description': 'The safety population included all participants who received at least one injection.', 'eventGroups': [{'id': 'EG000', 'title': 'Emervel Deep Lidocaine', 'description': 'NLFs were injected with Emervel Deep Lidocaine (20 mg/mL with 0.3% lidocaine).', 'otherNumAtRisk': 162, 'deathsNumAtRisk': 162, 'otherNumAffected': 16, 'seriousNumAtRisk': 162, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Juvederm Ultra Plus', 'description': 'NLFs were injected with Juvéderm Ultra Plus (24 mg/mL).', 'otherNumAtRisk': 162, 'deathsNumAtRisk': 162, 'otherNumAffected': 16, 'seriousNumAtRisk': 162, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 162, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 162, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 162, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'seriousEvents': [{'term': 'Colon cancer', 'notes': 'Event was unrelated to study product or injection procedure. If the treated side where an AE occurred was not applicable, this AE was summarized under each treatment group."', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Lung cancer metastatic', 'notes': 'Event was unrelated to study product or injection procedure. If the treated side where an AE occurred was not applicable, this AE was summarized under each treatment group."', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Uterine Leiomyoma', 'notes': 'Event was unrelated to study product or injection procedure. If the treated side where an AE occurred was not applicable, this AE was summarized under each treatment group."', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Herpes Zoster', 'notes': 'Event was unrelated to study product or injection procedure. If the treated side where an AE occurred was not applicable, this AE was summarized under each treatment group."', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Diarrhoea infections', 'notes': 'Event was unrelated to study product or injection procedure. If the treated side where an AE occurred was not applicable, this AE was summarized under each treatment group."', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Small intestinal obstruction', 'notes': 'Event was unrelated to study product or injection procedure. If the treated side where an AE occurred was not applicable, this AE was summarized under each treatment group."', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Lumbar Spinal stenosis', 'notes': 'Event was unrelated to study product or injection procedure. If the treated side where an AE occurred was not applicable, this AE was summarized under each treatment group."', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Ovarian Cyst', 'notes': 'Event was unrelated to study product or injection procedure. If the treated side where an AE occurred was not applicable, this AE was summarized under each treatment group."', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 24 After Final Initial Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Emervel Deep Lidocaine', 'description': 'NLFs were injected with Emervel Deep Lidocaine (20 mg/mL with 0.3% lidocaine).'}, {'id': 'OG001', 'title': 'Juvederm Ultra Plus', 'description': 'NLFs were injected with Juvéderm Ultra Plus (24 mg/mL).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24 after final initial injection (Week 24 for participants without touch-up injection, Week 27 for participants with touch-up injection at Week 3)', 'description': 'WSRS is a validated 5-point reference scale with photographs that classifies deep facial wrinkles (nasolabial folds). WSRS represents clinically meaningful change in NLF severity from the adjacent grades where 1= absent (no visible fold; continuous skin line), 2 = mild (shallow but visible fold with a slight indentation; minor facial feature; implant expected to produce a slight improvement in appearance), 3 = excellent (correction is expected from injectable implant), 4 = severe (very long and deep folds; prominent facial feature; less than 2 mm visible fold when stretched; significant improvement expected from injectable implant), 5 = extreme (extremely deep and long folds, detrimental to facial appearance; 2 to 4 millimeter (mm) visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone). A negative change from baseline indicates improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) population included participants who were randomized and received an injection on both treatment sides.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 3 After Final Initial Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Emervel Deep Lidocaine', 'description': 'NLFs were injected with Emervel Deep Lidocaine (20 mg/mL with 0.3% lidocaine).'}, {'id': 'OG001', 'title': 'Juvederm Ultra Plus', 'description': 'NLFs were injected with Juvéderm Ultra Plus (24 mg/mL).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '0.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 3 after final initial injection (Week 3 for participants without touch-up injection, Week 6 for participants with touch-up injection at Week 3)', 'description': 'WSRS is a validated 5-point reference scale with photographs that classifies deep facial wrinkles (nasolabial folds). WSRS represents a clinically meaningful change in nasolabial fold severity from the adjacent grades where 1 = absent (no visible fold; continuous skin line), 2 = mild (shallow but visible fold with a slight indentation; minor facial feature; implant is expected to produce a slight improvement in appearance), 3 = excellent (correction is expected from injectable implant), 4 = severe (very long and deep folds; prominent facial feature; less than 2 mm visible fold when stretched; significant improvement is expected from injectable implant), 5 = extreme (extremely deep and long folds, detrimental to facial appearance; 2 to 4 mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone). A negative change from baseline indicates improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included participants who were randomized and received an injection on both treatment sides.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 12 After Final Initial Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Emervel Deep Lidocaine', 'description': 'NLFs were injected with Emervel Deep Lidocaine (20 mg/mL with 0.3% lidocaine).'}, {'id': 'OG001', 'title': 'Juvederm Ultra Plus', 'description': 'NLFs were injected with Juvéderm Ultra Plus (24 mg/mL).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12 after final initial injection (Week 12 for participants without touch-up injection, Week 15 for participants with touch-up injection at Week 3)', 'description': 'WSRS is a validated 5-point reference scale with photographs that classifies deep facial wrinkles (nasolabial folds). WSRS represents a clinically meaningful change in nasolabial fold severity from the adjacent grades where 1 = absent (no visible fold; continuous skin line), 2 = mild (shallow but visible fold with a slight indentation; minor facial feature; implant is expected to produce a slight improvement in appearance), 3 = excellent (correction is expected from injectable implant), 4 = severe (very long and deep folds; prominent facial feature; less than 2 mm visible fold when stretched; significant improvement is expected from injectable implant), 5 = extreme (extremely deep and long folds, detrimental to facial appearance; 2 to 4 mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone). A negative change from baseline indicates improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included participants who were randomized and received an injection on both treatment sides.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 36 After Final Initial Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Emervel Deep Lidocaine', 'description': 'NLFs were injected with Emervel Deep Lidocaine (20 mg/mL with 0.3% lidocaine).'}, {'id': 'OG001', 'title': 'Juvederm Ultra Plus', 'description': 'NLFs were injected with Juvéderm Ultra Plus (24 mg/mL).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 36 after final initial injection (Week 36 for participants without touch-up injection, Week 39 for participants with touch-up injection at Week 3)', 'description': 'WSRS is a validated 5-point reference scale with photographs that classifies deep facial wrinkles (nasolabial folds). WSRS represents a clinically meaningful change in nasolabial fold severity from the adjacent grades where 1 = absent (no visible fold; continuous skin line), 2 = mild (shallow but visible fold with a slight indentation; minor facial feature; implant is expected to produce a slight improvement in appearance), 3 = excellent (correction is expected from injectable implant), 4 = severe (very long and deep folds; prominent facial feature; less than 2 mm visible fold when stretched; significant improvement is expected from injectable implant), 5 = extreme (extremely deep and long folds, detrimental to facial appearance; 2 to 4 mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone). A negative change from baseline indicates improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included participants who were randomized and received an injection on both treatment sides.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 48 After Final Initial Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Emervel Deep Lidocaine', 'description': 'NLFs were injected with Emervel Deep Lidocaine (20 mg/mL with 0.3% lidocaine).'}, {'id': 'OG001', 'title': 'Juvederm Ultra Plus', 'description': 'NLFs were injected with Juvéderm Ultra Plus (24 mg/mL).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48 after final initial injection (Week 48 for participants without touch-up injection, Week 51 for participants with touch-up injection at Week 3)', 'description': 'WSRS is a nasolabial fold severity from the adjacent grades where 1 = absent (no visible fold; continuous skin line), 2 = mild (shallow but visible fold with a slight indentation; minor facial feature; implant is expected to produce a slight improvement in appearance), 3 = excellent (correction is expected from injectable implant), 4 = severe (very long and deep folds; prominent facial feature; less than 2 mm visible fold when stretched; significant improvement is expected from injectable implant), 5 = extreme (extremely deep and long folds, detrimental to facial appearance; 2 to 4 mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone). A negative change from baseline indicates improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included participants who were randomized and received an injection on both treatment sides.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Participant Self-Assessment of Wrinkle Severity at Week 24 After Final Initial Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Emervel Deep Lidocaine', 'description': 'NLFs were injected with Emervel Deep Lidocaine (20 mg/mL with 0.3% lidocaine).'}, {'id': 'OG001', 'title': 'Juvederm Ultra Plus', 'description': 'NLFs were injected with Juvéderm Ultra Plus (24 mg/mL).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24 after final initial injection (Week 24 for participants without touch-up injection, Week 27 for participants with touch-up injection at Week 3)', 'description': 'Participants self-assessment was measured by using a wrinkle severity scale with 1 being absent and 5 being extreme. Each participant was to perform an assessment of the wrinkle severity based on self-assessment score: 1= Absent (No visible fold; continuous skin line), 2= Mild (Shallow but visible fold with a slight indentation), 3= Moderate (Moderately deep folds), 4= Severe (Very long and deep fold), 5= Extreme (Extremely deep and long folds). A negative change from baseline indicates improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included participants who were randomized and received an injection on both treatment sides.'}, {'type': 'SECONDARY', 'title': 'Participant Pain Assessment After the Initial Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Emervel Deep Lidocaine', 'description': 'NLFs were injected with Emervel Deep Lidocaine (20 mg/mL with 0.3% lidocaine).'}, {'id': 'OG001', 'title': 'Juvederm Ultra Plus', 'description': 'NLFs were injected with Juvéderm Ultra Plus (24 mg/mL).'}], 'classes': [{'title': 'At 0 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'At 15 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'At 30 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'At 45 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'At 60 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'At 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 0 ,15, 30, 45, 60 minutes and 24 hours after the initial injection (Baseline)', 'description': 'Participant pain severity for each NLF was assessed at time 0, 15, 30, 45, 60 minutes and 24 hours after the initial injection using an 11-point Numeric Pain Intensity Scale (NPIS).The NPIS was a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with 0 is no pain and 10 is the worst possible pain where a lower score correlates to better outcome for pain.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included participants who were randomized and received an injection on both treatment sides. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints.'}, {'type': 'SECONDARY', 'title': 'Participant Pain Assessment After the Initial Touch-up Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Emervel Deep Lidocaine', 'description': 'NLFs were injected with Emervel Deep Lidocaine (20 mg/mL with 0.3% lidocaine).'}, {'id': 'OG001', 'title': 'Juvederm Ultra Plus', 'description': 'NLFs were injected with Juvéderm Ultra Plus (24 mg/mL).'}], 'classes': [{'title': 'At 0 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'At 15 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'At 30 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'At 45 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'At 60 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'At 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 0, 15, 30, 45, 60 minutes and 24 hours after the Initial Touch-up Injection (At 3 weeks after initial injection)', 'description': 'Participant pain severity for each NLF was assessed at time 0, 15, 30, 45, 60 minutes and 24 hours after the initial injection using NPIS. The NPIS was a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with 0 is no pain and 10 is the worst possible pain where a lower score correlates to better outcome for pain.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included participants who were randomized and received an injection on both treatment sides. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Event (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Emervel Deep Lidocaine', 'description': 'NLFs were injected with Emervel Deep Lidocaine (20 mg/mL with 0.3% lidocaine).'}, {'id': 'OG001', 'title': 'Juvederm Ultra Plus', 'description': 'NLFs were injected with Juvéderm Ultra Plus (24 mg/mL).'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study drug administration up to 62 weeks', 'description': 'AE was defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the study drug. Number of participants with AEs were reported. Event was unrelated to study product or injection procedure. If the treated side where an AE occurred was not applicable, this AE was summarized under each treatment group."', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least one injection.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'Participants were randomized to receive either Emervel Deep Lidocaine (20 milligram per milliliter \\[mg/mL\\] with 0.3% lidocaine) injection in the left nasolabial fold (NLF) and Juvederm Ultra Plus (24 mg/mL) injection in to the right NLF or Juvederm Ultra Plus (24 mg/mL) injection in the left NLF and Emervel Deep Lidocaine (20 mg/mL with 0.3% lidocaine) injection in the right NLF.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}]}, {'type': 'Emervel Deep Lidocaine in Left NLF Followed by Juvederm Ultra in Right NLF', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}]}, {'type': 'Juvederm Ultra in Left NLF Followed by Emervel Deep Lidocaine in Right NLF', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '136'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Clinical Investigational Plan Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was conducted at 11 sites in the United States from 27 September 2010 to 12 January 2012.', 'preAssignmentDetails': 'A total of 184 participants were screened, of which 162 participants received treatment in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Emervel Deep Lidocaine in Left NLF Followed by Juvederm Ultra Plus in Right NLF', 'description': 'Participants received Emervel Deep Lidocaine (20 mg/mL with 0.3% lidocaine) injection into the left NLF and Juvéderm Ultra Plus (24 mg/mL) in the right NLF.'}, {'id': 'BG001', 'title': 'Juvederm Ultra Plus in Left NLF Followed by Emervel Deep Lidocaine in Right NLF', 'description': 'Participants received Juvéderm Ultra Plus (24 mg/mL) injection into the left NLF and Emervel Deep Lidocaine (20 mg/mL with 0.3% lidocaine) injection in the right NLF.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.4', 'spread': '9.29', 'groupId': 'BG000'}, {'value': '54.0', 'spread': '8.09', 'groupId': 'BG001'}, {'value': '53.7', 'spread': '8.68', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Caucasian', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Skin Type', 'classes': [{'categories': [{'title': 'Type I', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Type II', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Type III', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}, {'title': 'Type IV', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Type V', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Type VI', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Skin Type I = White; very fair, red or blonde hair blue eyes; freckles; Always burns, never tans Skin Type II = White, fair, red or blond hair; blue, hazel or green eyes; Usually burns, tans with difficulty Skin Type III = Cream white; fair with any eye or hair color (common); Sometimes mild burn, gradually tans Skin Type IV = Brown; typical Mediterranean Caucasian skin; Rarely burns, tans with ease Skin Type V = Dark Brown; mid-eastern skin types; Very rarely burns, tans easily Skin Type VI = Black; Never burns, tans very easily', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The intent-to-treat population included all participants who were randomized and received an injection on both treatment sides.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'dispFirstSubmitDate': '2012-08-28', 'completionDateStruct': {'date': '2012-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-25', 'studyFirstSubmitDate': '2010-09-16', 'dispFirstSubmitQcDate': '2012-08-28', 'resultsFirstSubmitDate': '2023-08-04', 'studyFirstSubmitQcDate': '2010-09-16', 'dispFirstPostDateStruct': {'date': '2012-09-03', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-25', 'studyFirstPostDateStruct': {'date': '2010-09-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 24 After Final Initial Injection', 'timeFrame': 'Baseline, Week 24 after final initial injection (Week 24 for participants without touch-up injection, Week 27 for participants with touch-up injection at Week 3)', 'description': 'WSRS is a validated 5-point reference scale with photographs that classifies deep facial wrinkles (nasolabial folds). WSRS represents clinically meaningful change in NLF severity from the adjacent grades where 1= absent (no visible fold; continuous skin line), 2 = mild (shallow but visible fold with a slight indentation; minor facial feature; implant expected to produce a slight improvement in appearance), 3 = excellent (correction is expected from injectable implant), 4 = severe (very long and deep folds; prominent facial feature; less than 2 mm visible fold when stretched; significant improvement expected from injectable implant), 5 = extreme (extremely deep and long folds, detrimental to facial appearance; 2 to 4 millimeter (mm) visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone). A negative change from baseline indicates improvement.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 3 After Final Initial Injection', 'timeFrame': 'Baseline, Week 3 after final initial injection (Week 3 for participants without touch-up injection, Week 6 for participants with touch-up injection at Week 3)', 'description': 'WSRS is a validated 5-point reference scale with photographs that classifies deep facial wrinkles (nasolabial folds). WSRS represents a clinically meaningful change in nasolabial fold severity from the adjacent grades where 1 = absent (no visible fold; continuous skin line), 2 = mild (shallow but visible fold with a slight indentation; minor facial feature; implant is expected to produce a slight improvement in appearance), 3 = excellent (correction is expected from injectable implant), 4 = severe (very long and deep folds; prominent facial feature; less than 2 mm visible fold when stretched; significant improvement is expected from injectable implant), 5 = extreme (extremely deep and long folds, detrimental to facial appearance; 2 to 4 mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone). A negative change from baseline indicates improvement.'}, {'measure': 'Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 12 After Final Initial Injection', 'timeFrame': 'Baseline, Week 12 after final initial injection (Week 12 for participants without touch-up injection, Week 15 for participants with touch-up injection at Week 3)', 'description': 'WSRS is a validated 5-point reference scale with photographs that classifies deep facial wrinkles (nasolabial folds). WSRS represents a clinically meaningful change in nasolabial fold severity from the adjacent grades where 1 = absent (no visible fold; continuous skin line), 2 = mild (shallow but visible fold with a slight indentation; minor facial feature; implant is expected to produce a slight improvement in appearance), 3 = excellent (correction is expected from injectable implant), 4 = severe (very long and deep folds; prominent facial feature; less than 2 mm visible fold when stretched; significant improvement is expected from injectable implant), 5 = extreme (extremely deep and long folds, detrimental to facial appearance; 2 to 4 mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone). A negative change from baseline indicates improvement.'}, {'measure': 'Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 36 After Final Initial Injection', 'timeFrame': 'Baseline, Week 36 after final initial injection (Week 36 for participants without touch-up injection, Week 39 for participants with touch-up injection at Week 3)', 'description': 'WSRS is a validated 5-point reference scale with photographs that classifies deep facial wrinkles (nasolabial folds). WSRS represents a clinically meaningful change in nasolabial fold severity from the adjacent grades where 1 = absent (no visible fold; continuous skin line), 2 = mild (shallow but visible fold with a slight indentation; minor facial feature; implant is expected to produce a slight improvement in appearance), 3 = excellent (correction is expected from injectable implant), 4 = severe (very long and deep folds; prominent facial feature; less than 2 mm visible fold when stretched; significant improvement is expected from injectable implant), 5 = extreme (extremely deep and long folds, detrimental to facial appearance; 2 to 4 mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone). A negative change from baseline indicates improvement.'}, {'measure': 'Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 48 After Final Initial Injection', 'timeFrame': 'Baseline, Week 48 after final initial injection (Week 48 for participants without touch-up injection, Week 51 for participants with touch-up injection at Week 3)', 'description': 'WSRS is a nasolabial fold severity from the adjacent grades where 1 = absent (no visible fold; continuous skin line), 2 = mild (shallow but visible fold with a slight indentation; minor facial feature; implant is expected to produce a slight improvement in appearance), 3 = excellent (correction is expected from injectable implant), 4 = severe (very long and deep folds; prominent facial feature; less than 2 mm visible fold when stretched; significant improvement is expected from injectable implant), 5 = extreme (extremely deep and long folds, detrimental to facial appearance; 2 to 4 mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone). A negative change from baseline indicates improvement.'}, {'measure': 'Mean Change From Baseline in Participant Self-Assessment of Wrinkle Severity at Week 24 After Final Initial Injection', 'timeFrame': 'Baseline, Week 24 after final initial injection (Week 24 for participants without touch-up injection, Week 27 for participants with touch-up injection at Week 3)', 'description': 'Participants self-assessment was measured by using a wrinkle severity scale with 1 being absent and 5 being extreme. Each participant was to perform an assessment of the wrinkle severity based on self-assessment score: 1= Absent (No visible fold; continuous skin line), 2= Mild (Shallow but visible fold with a slight indentation), 3= Moderate (Moderately deep folds), 4= Severe (Very long and deep fold), 5= Extreme (Extremely deep and long folds). A negative change from baseline indicates improvement.'}, {'measure': 'Participant Pain Assessment After the Initial Injection', 'timeFrame': 'At 0 ,15, 30, 45, 60 minutes and 24 hours after the initial injection (Baseline)', 'description': 'Participant pain severity for each NLF was assessed at time 0, 15, 30, 45, 60 minutes and 24 hours after the initial injection using an 11-point Numeric Pain Intensity Scale (NPIS).The NPIS was a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with 0 is no pain and 10 is the worst possible pain where a lower score correlates to better outcome for pain.'}, {'measure': 'Participant Pain Assessment After the Initial Touch-up Injection', 'timeFrame': 'At 0, 15, 30, 45, 60 minutes and 24 hours after the Initial Touch-up Injection (At 3 weeks after initial injection)', 'description': 'Participant pain severity for each NLF was assessed at time 0, 15, 30, 45, 60 minutes and 24 hours after the initial injection using NPIS. The NPIS was a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with 0 is no pain and 10 is the worst possible pain where a lower score correlates to better outcome for pain.'}, {'measure': 'Number of Participants With Adverse Event (AEs)', 'timeFrame': 'From start of study drug administration up to 62 weeks', 'description': 'AE was defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the study drug. Number of participants with AEs were reported. Event was unrelated to study product or injection procedure. If the treated side where an AE occurred was not applicable, this AE was summarized under each treatment group."'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Skin Wrinkling']}, 'descriptionModule': {'briefSummary': 'The purpose of the study was to compare the effectiveness and safety of Emervel Deep Lidocaine versus Juvederm Ultra Plus in the treatment of moderate to severe facial wrinkles and folds.', 'detailedDescription': 'This was a randomized, evaluator-blinded, active-controlled, multi-center, split-face comparison study of Emervel Deep Lidocaine versus Juvederm Ultra Plus in the treatment of moderate to severe facial wrinkles and folds. Two physicians, an Unblinded Injecting Investigator and a Blinded Evaluating Investigator, were required at each study center. The Unblinded Injecting Investigator was different from the Blinded Evaluating Investigator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The subject was a male or female 18 years of age or older\n* The subject had bilateral nasolabial folds that, in the opinion of both the blinded evaluating investigator and the unblinded injecting investigator, was corrected with an injectable dermal implant\n* The subject had the same Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 (moderate or severe) for each nasolabial fold\n\nExclusion Criteria:\n\n* The subject had active skin disease or inflammation on or near a nasolabial fold that, in the principal investigator's opinion, would interfere with the study device injections and/or study assessments.\n* The subject had a history of sensitivity to hyaluronic acid\n* The subject had a history of sensitivity to lidocaine or other amide type anesthetics\n* The subject was, in the principal investigator's opinion, at undue risk based on the precautions, warnings and contraindications for local lidocaine anesthetics."}, 'identificationModule': {'nctId': 'NCT01205061', 'briefTitle': 'Emervel® Deep Lidocaine vs. Juvederm® Ultra Plus in Treatment of Moderate to Severe Facial Wrinkles and Folds', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'A Pivotal USA Randomized, Evaluator-blinded, Active-controlled, Multi-center, Split-face Comparison Study of Emervel® Deep Lidocaine Versus Juvederm® Ultra Plus in the Treatment of Moderate to Severe Facial Wrinkles and Folds', 'orgStudyIdInfo': {'id': 'RD.06.CIP.18159'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Emervel Deep Lidocaine', 'description': 'NLFs (Nasolabial Folds) were injected with Emervel Deep Lidocaine (20 mg/mL with 0.3% lidocaine).', 'interventionNames': ['Device: Emervel Deep Lidocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Juvederm Ultra Plus', 'description': 'NLFs were injected with Juvéderm Ultra Plus (24 mg/mL).', 'interventionNames': ['Device: Juvederm Ultra Plus']}], 'interventions': [{'name': 'Emervel Deep Lidocaine', 'type': 'DEVICE', 'description': '20 mg/mL + 0.3% lidocaine', 'armGroupLabels': ['Emervel Deep Lidocaine']}, {'name': 'Juvederm Ultra Plus', 'type': 'DEVICE', 'description': '24mg/mL', 'armGroupLabels': ['Juvederm Ultra Plus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Galderma research site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Galderma research site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Galderma research site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Galderma research site', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '30078', 'city': 'Snellville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Galderma research site', 'geoPoint': {'lat': 33.85733, 'lon': -84.01991}}, {'zip': '21030', 'city': 'Hunt Valley', 'state': 'Maryland', 'country': 'United States', 'facility': 'Galderma research site', 'geoPoint': {'lat': 39.49983, 'lon': -76.64108}}, {'zip': '48088', 'city': 'Warren', 'state': 'Michigan', 'country': 'United States', 'facility': 'Galderma research site', 'geoPoint': {'lat': 42.49044, 'lon': -83.01304}}, {'zip': '10604', 'city': 'White Plains', 'state': 'New York', 'country': 'United States', 'facility': 'Galderma research site', 'geoPoint': {'lat': 41.03399, 'lon': -73.76291}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Galderma research site', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Galderma research site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Galderma research site', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}], 'overallOfficials': [{'name': 'Clinical Operations, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Galderma R&D'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}