Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-03-11 @ 4:43 PM
Study NCT ID:
NCT01522456
Status:
COMPLETED
Last Update Posted:
2022-08-01
First Post:
2012-01-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Split-face Tolerability Comparison Between Adapalene-Benzoyl Peroxide Gel Versus Tretinoin Gel
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'elizabeth.nieman@galderma.com', 'phone': '817-961-5130', 'title': 'Elizabeth M. Nieman, Associate Medical Information Specialist', 'organization': 'Galderma Laboratories, L.P.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 - Day 22', 'eventGroups': [{'id': 'EG000', 'title': 'Epiduo Gel', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.', 'otherNumAtRisk': 73, 'otherNumAffected': 16, 'seriousNumAtRisk': 73, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Retin-A Micro Microsphere 0.1%', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.', 'otherNumAtRisk': 73, 'otherNumAffected': 16, 'seriousNumAtRisk': 73, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Non-application Site', 'description': 'Adverse events occurring on non-application sites', 'otherNumAtRisk': 73, 'otherNumAffected': 0, 'seriousNumAtRisk': 73, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Skin Burning Sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Epilepsy', 'notes': 'Epileptic seizure not related to study medicines.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Worst Postbaseline Tolerability (Erythema)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epiduo Gel', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG001', 'title': 'Retin-A Micro Microsphere 0.1%', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 - Day 22', 'description': 'Worst postbaseline tolerability assessment for erythema.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Tolerability at Day 22 (Erythema)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epiduo Gel', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG001', 'title': 'Retin-A Micro Microsphere 0.1%', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Data Missing', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22', 'description': 'Tolerability assessments at day 22 for erythema', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Tolerability at Day 22 (Dryness)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epiduo Gel', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG001', 'title': 'Retin-A Micro Microsphere 0.1%', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Data Missing', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22', 'description': 'Tolerability assessments at day 22 for dryness', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'User Preference Survey (Investigator)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epiduo Gel', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG001', 'title': 'Retin-A Micro Microsphere 0.1%', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}], 'classes': [{'title': 'Day 5 (n=69)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Day 12 (n=67)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Day 19 (n=65)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Day 22 (n=72)', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 5, day 12, day 19, and day 22', 'description': 'Response from investigator when asked: "Which side of the face appears to be less irritated?" Data collected from available participants.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'User Preference Survey (Subjects)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epiduo Gel', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG001', 'title': 'Retin-A Micro Microsphere 0.1%', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}], 'classes': [{'title': 'Day 5 (n=69)', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Day 12 (n=67)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Day 19 (n=65)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Day 22 (n=72)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 5, day 12, day 19, and day 22', 'description': 'Response from subjects when asked: "Which side of the face feels less irritated?" Data collected from available participants on each assessment day.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'PRIMARY', 'title': 'Worst Postbaseline Tolerability (Scaling)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epiduo Gel', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG001', 'title': 'Retin-A Micro Microsphere 0.1%', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 - Day 22', 'description': 'Worst postbaseline assessment for scaling.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'PRIMARY', 'title': 'Worst Postbaseline Tolerability (Dryness)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epiduo Gel', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG001', 'title': 'Retin-A Micro Microsphere 0.1%', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 - Day 22', 'description': 'Worst postbaseline tolerability assessments for dryness.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Tolerability at Day 22 (Scaling)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epiduo Gel', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG001', 'title': 'Retin-A Micro Microsphere 0.1%', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Data Missing', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22', 'description': 'Tolerability assessments at day 22 for scaling', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'PRIMARY', 'title': 'Worst Postbaseline Tolerability (Stinging/Burning)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epiduo Gel', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG001', 'title': 'Retin-A Micro Microsphere 0.1%', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 - Day 22', 'description': 'Worst postbaseline tolerability assessments for stinging/burning', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Tolerability at Day 22 (Stinging/Burning)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epiduo Gel', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG001', 'title': 'Retin-A Micro Microsphere 0.1%', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Data Missing', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22', 'description': 'Tolerability assessments at day 22 for stinging/burning', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Cumulative Tolerability (Erythema)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epiduo Gel', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG001', 'title': 'Retin-A Micro Microsphere 0.1%', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}], 'classes': [{'title': '1', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '164', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}]}, {'title': '8', 'categories': [{'measurements': [{'value': '207', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}]}, {'title': '9', 'categories': [{'measurements': [{'value': '244', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}]}, {'title': '10', 'categories': [{'measurements': [{'value': '287', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}]}, {'title': '11', 'categories': [{'measurements': [{'value': '323', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}]}]}, {'title': '12', 'categories': [{'measurements': [{'value': '370', 'groupId': 'OG000'}, {'value': '334', 'groupId': 'OG001'}]}]}, {'title': '15', 'categories': [{'measurements': [{'value': '410', 'groupId': 'OG000'}, {'value': '368', 'groupId': 'OG001'}]}]}, {'title': '16', 'categories': [{'measurements': [{'value': '447', 'groupId': 'OG000'}, {'value': '400', 'groupId': 'OG001'}]}]}, {'title': '17', 'categories': [{'measurements': [{'value': '483', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}]}, {'title': '18', 'categories': [{'measurements': [{'value': '517', 'groupId': 'OG000'}, {'value': '464', 'groupId': 'OG001'}]}]}, {'title': '19', 'categories': [{'measurements': [{'value': '550', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}]}]}, {'title': '22', 'categories': [{'measurements': [{'value': '583', 'groupId': 'OG000'}, {'value': '529', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 - Day 22', 'description': 'Cumulative tolerability assessments for erythema. Cumulative tolerability is defined as the sum of the tolerability scores for erythema. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.', 'unitOfMeasure': 'scores on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Cumulative Tolerability (Scaling)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epiduo Gel', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG001', 'title': 'Retin-A Micro Microsphere 0.1%', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}], 'classes': [{'title': '1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': '8', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': '9', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': '10', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}, {'title': '11', 'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}, {'title': '12', 'categories': [{'measurements': [{'value': '182', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}]}, {'title': '15', 'categories': [{'measurements': [{'value': '211', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}]}, {'title': '16', 'categories': [{'measurements': [{'value': '228', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}]}, {'title': '17', 'categories': [{'measurements': [{'value': '246', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}]}, {'title': '18', 'categories': [{'measurements': [{'value': '259', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}]}]}, {'title': '19', 'categories': [{'measurements': [{'value': '277', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}]}, {'title': '22', 'categories': [{'measurements': [{'value': '295', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 - Day 22', 'description': 'Cumulative tolerability assessments for scaling. Cumulative tolerability is defined as the sum of the tolerability scores for scaling. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.', 'unitOfMeasure': 'scores on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Cumulative Tolerability (Dryness)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epiduo Gel', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG001', 'title': 'Retin-A Micro Microsphere 0.1%', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}], 'classes': [{'title': '1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': '8', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': '9', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': '10', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': '11', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': '12', 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}]}, {'title': '15', 'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}]}, {'title': '16', 'categories': [{'measurements': [{'value': '178', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}]}, {'title': '17', 'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}]}, {'title': '18', 'categories': [{'measurements': [{'value': '231', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}]}, {'title': '19', 'categories': [{'measurements': [{'value': '256', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}]}, {'title': '22', 'categories': [{'measurements': [{'value': '281', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 - Day 22', 'description': 'Cumulative tolerability assessments for dryness. Cumulative tolerability is defined as the sum of the tolerability scores for dryness. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.', 'unitOfMeasure': 'scores on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Cumulative Tolerability (Stinging/Burning)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epiduo Gel', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG001', 'title': 'Retin-A Micro Microsphere 0.1%', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}], 'classes': [{'title': '1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': '8', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': '9', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': '10', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': '11', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': '12', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': '15', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': '16', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': '17', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': '18', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': '19', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': '22', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 - Day 22', 'description': 'Cumulative tolerability assessments for stinging/burning. Cumulative tolerability is defined as the sum of the tolerability scores stinging/burning. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.', 'unitOfMeasure': 'scores on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Cumulative Tolerability (Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epiduo Gel', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG001', 'title': 'Retin-A Micro Microsphere 0.1%', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}], 'classes': [{'title': '1', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '212', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}]}, {'title': '8', 'categories': [{'measurements': [{'value': '298', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}]}, {'title': '9', 'categories': [{'measurements': [{'value': '392', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}]}]}, {'title': '10', 'categories': [{'measurements': [{'value': '510', 'groupId': 'OG000'}, {'value': '427', 'groupId': 'OG001'}]}]}, {'title': '11', 'categories': [{'measurements': [{'value': '613', 'groupId': 'OG000'}, {'value': '531', 'groupId': 'OG001'}]}]}, {'title': '12', 'categories': [{'measurements': [{'value': '740', 'groupId': 'OG000'}, {'value': '663', 'groupId': 'OG001'}]}]}, {'title': '15', 'categories': [{'measurements': [{'value': '834', 'groupId': 'OG000'}, {'value': '756', 'groupId': 'OG001'}]}]}, {'title': '16', 'categories': [{'measurements': [{'value': '914', 'groupId': 'OG000'}, {'value': '835', 'groupId': 'OG001'}]}]}, {'title': '17', 'categories': [{'measurements': [{'value': '995', 'groupId': 'OG000'}, {'value': '914', 'groupId': 'OG001'}]}]}, {'title': '18', 'categories': [{'measurements': [{'value': '1068', 'groupId': 'OG000'}, {'value': '994', 'groupId': 'OG001'}]}]}, {'title': '19', 'categories': [{'measurements': [{'value': '1144', 'groupId': 'OG000'}, {'value': '1073', 'groupId': 'OG001'}]}]}, {'title': '22', 'categories': [{'measurements': [{'value': '1220', 'groupId': 'OG000'}, {'value': '1158', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 - Day 22', 'description': 'Cumulative tolerability assessments for erythema, scaling, dryness, and stinging/burning. Cumulative tolerability is defined as the sum of the tolerability scores for erythema, scaling, dryness, or stinging/burning. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.', 'unitOfMeasure': 'scores on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Overall Tolerability Preference Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epiduo Gel', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG001', 'title': 'Retin-A Micro Microsphere 0.1%', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}], 'classes': [{'title': '____ spread easier (n=71)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': '____ absorbed quicker into my skin (n=71)', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': '____ had a more pleasant smell (n=71)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': '____ felt better on my skin (n=71)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': '____ left smaller amount of residue on skin (n=71)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Overall, I prefer ____ (n=71)', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22', 'description': 'Overall tolerability preference survey taken by the subjects. Data collected from available subjects on day 22.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'POST_HOC', 'title': 'Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Epiduo Gel (Fitzpatrick Skin Types I-III)', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG001', 'title': 'Retin-A Micro (Fitzpatrick Skin Types I-III)', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}, {'id': 'OG002', 'title': 'Epiduo Gel (Fitzpatrick Skin Types IV-VI)', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG003', 'title': 'Retin-A Micro (Fitzpatrick Skin Types IV-VI)', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 - Day 22', 'description': 'Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Erythema. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'POST_HOC', 'title': 'Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Scaling)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Epiduo Gel (Fitzpatrick Skin Types I-III)', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG001', 'title': 'Retin-A Micro (Fitzpatrick Skin Types I-III)', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}, {'id': 'OG002', 'title': 'Epiduo Gel (Fitzpatrick Skin Types IV-VI)', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG003', 'title': 'Retin-A Micro (Fitzpatrick Skin Types IV-VI)', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 - Day 22', 'description': 'Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Scaling. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'POST_HOC', 'title': 'Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Dryness)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Epiduo Gel (Fitzpatrick Skin Types I-III)', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG001', 'title': 'Retin-A Micro (Fitzpatrick Skin Types I-III)', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}, {'id': 'OG002', 'title': 'Epiduo Gel (Fitzpatrick Skin Types IV-VI)', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG003', 'title': 'Retin-A Micro (Fitzpatrick Skin Types IV-VI)', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 - Day 22', 'description': 'Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Dryness. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'POST_HOC', 'title': 'Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Epiduo Gel (Fitzpatrick Skin Types I-III)', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG001', 'title': 'Retin-A Micro (Fitzpatrick Skin Types I-III)', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}, {'id': 'OG002', 'title': 'Epiduo Gel (Fitzpatrick Skin Types IV-VI)', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG003', 'title': 'Retin-A Micro (Fitzpatrick Skin Types IV-VI)', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 - Day 22', 'description': 'Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Stinging/Burning. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'POST_HOC', 'title': 'Fitzpatrick Skin Type User Preference Survey at Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Epiduo Gel (Fitzpatrick Skin Types I-III)', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG001', 'title': 'Retin-A Micro (Fitzpatrick Skin Types I-III)', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}, {'id': 'OG002', 'title': 'Epiduo Gel (Fitzpatrick Skin Types IV-VI)', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG003', 'title': 'Retin-A Micro (Fitzpatrick Skin Types IV-VI)', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}], 'classes': [{'title': 'Spread more easily', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Absorbed more quickly', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Smelled better', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Felt better', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Left less residue', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Overall', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22', 'description': 'User Preference Survey at Day 22 (Safety Population) Grouped by Fitzpatrick Skin Type. Fitzpatrick skin type (FST) is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin). Two subjects did not participate in the User Preference Survey; as a result, 2 subjects were not included in the FST I - III group results below.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Fitzpatrick Skin Type Overall Tolerability Preference Survey Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Epiduo Gel (Fitzpatrick Skin Types I-III)', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG001', 'title': 'Retin-A Micro (Fitzpatrick Skin Types I-III)', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}, {'id': 'OG002', 'title': 'Epiduo Gel (Fitzpatrick Skin Types IV-VI)', 'description': 'Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel\n\nEpiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.'}, {'id': 'OG003', 'title': 'Retin-A Micro (Fitzpatrick Skin Types IV-VI)', 'description': 'Tretinoin gel, 0.1%\n\nRetin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.'}], 'classes': [{'title': 'Overall tolerability preference-investigator', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'Overall tolerability preference - subject', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22', 'description': 'Overall Tolerability Preference Survey Results at Day 22 (Safety Population) Grouped by Fitzpatrick Skin Type (FST). Data collected from available subjects on day 22. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin). One subject did not participate in the User Preference Survey; as a result, 1 subject was not included in the FST I - III group results below.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Total Participants', 'description': 'All subjects randomized into the trial who received Epiduo Gel and Retin-A Micro 0.1% gel on each side of the face'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Tolerability Assessment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Total Participants', 'description': 'All subjects randomized into the trial who received Epiduo Gel and Retin-A Micro 0.1% gel on each side of the face'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.8', 'spread': '9.57', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-28', 'studyFirstSubmitDate': '2012-01-23', 'resultsFirstSubmitDate': '2013-03-11', 'studyFirstSubmitQcDate': '2012-01-27', 'lastUpdatePostDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-08-10', 'studyFirstPostDateStruct': {'date': '2012-01-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'User Preference Survey (Investigator)', 'timeFrame': 'Day 5, day 12, day 19, and day 22', 'description': 'Response from investigator when asked: "Which side of the face appears to be less irritated?" Data collected from available participants.'}, {'measure': 'User Preference Survey (Subjects)', 'timeFrame': 'Day 5, day 12, day 19, and day 22', 'description': 'Response from subjects when asked: "Which side of the face feels less irritated?" Data collected from available participants on each assessment day.'}, {'measure': 'Overall Tolerability Preference Survey', 'timeFrame': 'Day 22', 'description': 'Overall tolerability preference survey taken by the subjects. Data collected from available subjects on day 22.'}], 'primaryOutcomes': [{'measure': 'Worst Postbaseline Tolerability (Erythema)', 'timeFrame': 'Day 1 - Day 22', 'description': 'Worst postbaseline tolerability assessment for erythema.'}, {'measure': 'Worst Postbaseline Tolerability (Scaling)', 'timeFrame': 'Day 1 - Day 22', 'description': 'Worst postbaseline assessment for scaling.'}, {'measure': 'Worst Postbaseline Tolerability (Dryness)', 'timeFrame': 'Day 1 - Day 22', 'description': 'Worst postbaseline tolerability assessments for dryness.'}, {'measure': 'Worst Postbaseline Tolerability (Stinging/Burning)', 'timeFrame': 'Day 1 - Day 22', 'description': 'Worst postbaseline tolerability assessments for stinging/burning'}], 'secondaryOutcomes': [{'measure': 'Tolerability at Day 22 (Erythema)', 'timeFrame': 'Day 22', 'description': 'Tolerability assessments at day 22 for erythema'}, {'measure': 'Tolerability at Day 22 (Dryness)', 'timeFrame': 'Day 22', 'description': 'Tolerability assessments at day 22 for dryness'}, {'measure': 'Tolerability at Day 22 (Scaling)', 'timeFrame': 'Day 22', 'description': 'Tolerability assessments at day 22 for scaling'}, {'measure': 'Tolerability at Day 22 (Stinging/Burning)', 'timeFrame': 'Day 22', 'description': 'Tolerability assessments at day 22 for stinging/burning'}, {'measure': 'Cumulative Tolerability (Erythema)', 'timeFrame': 'Day 1 - Day 22', 'description': 'Cumulative tolerability assessments for erythema. Cumulative tolerability is defined as the sum of the tolerability scores for erythema. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.'}, {'measure': 'Cumulative Tolerability (Scaling)', 'timeFrame': 'Day 1 - Day 22', 'description': 'Cumulative tolerability assessments for scaling. Cumulative tolerability is defined as the sum of the tolerability scores for scaling. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.'}, {'measure': 'Cumulative Tolerability (Dryness)', 'timeFrame': 'Day 1 - Day 22', 'description': 'Cumulative tolerability assessments for dryness. Cumulative tolerability is defined as the sum of the tolerability scores for dryness. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.'}, {'measure': 'Cumulative Tolerability (Stinging/Burning)', 'timeFrame': 'Day 1 - Day 22', 'description': 'Cumulative tolerability assessments for stinging/burning. Cumulative tolerability is defined as the sum of the tolerability scores stinging/burning. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.'}, {'measure': 'Cumulative Tolerability (Combined)', 'timeFrame': 'Day 1 - Day 22', 'description': 'Cumulative tolerability assessments for erythema, scaling, dryness, and stinging/burning. Cumulative tolerability is defined as the sum of the tolerability scores for erythema, scaling, dryness, or stinging/burning. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'To compare the tolerability of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% to Retin-A Micro® (tretinoin gel) microsphere when used by subjects with acne vulgaris for 3 weeks in terms of local tolerability parameters (erythema, dryness, scaling, stinging/burning) and preference.', 'detailedDescription': 'Adult subjects with acne vulgaris will receive tretinoin gel 0.1% on one side of the face and adapalene 0.1% / benzoyl peroxide 2.5% gel on the other side of the face once daily for a period 3 weeks (22 days). Tolerability assessments (erythema, dryness, scaling, stinging/burning)on both sides of the face will be taken on each visit, on each weekday from from baseline to day 22. The investigator and subjects will respond to user preference questions on days 5, 12, 19, and 22.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects of any race\n* Subjects 18 years or older\n* Subjects with acne vulgaris\n\nExclusion Criteria:\n\n* Subjects with an allergy to a component of the study drugs (refer to the package inserts for Epiduo Gel and Retin-A Micro 0.1%)\n* Subjects with a washout period for topical treatment (less than 1 week for corticosteroids or 4 weeks for retinoids)\n* Subjects with a washout period for systemic treatment (less than 1 week for medications that may have increased photosensitivity or 4 weeks for corticosteroids or 24 weeks for oral retinoids)\n* Subjects with a sunburn, eczema, atopic dermatitis, perioral dermatitis, rosacea, or other topical conditions on the treatment area\n* Subjects with planned unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc)'}, 'identificationModule': {'nctId': 'NCT01522456', 'briefTitle': 'Split-face Tolerability Comparison Between Adapalene-Benzoyl Peroxide Gel Versus Tretinoin Gel', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'Split-face Tolerability Comparison Between Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Versus Retin-A Micro® (Tretinoin Gel) Microsphere, 0.1% in Subjects With Acne Vulgaris', 'orgStudyIdInfo': {'id': 'US10201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Epiduo Gel', 'description': 'Adapalene 0.1% and benzoyl peroxide 2.5% gel', 'interventionNames': ['Drug: Epiduo Gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Retin-A Micro Microsphere 0.1%', 'description': 'Tretinoin gel, 0.1%', 'interventionNames': ['Drug: Retin-A Micro Microsphere 0.1%']}], 'interventions': [{'name': 'Epiduo Gel', 'type': 'DRUG', 'description': 'Once-daily application of fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.', 'armGroupLabels': ['Epiduo Gel']}, {'name': 'Retin-A Micro Microsphere 0.1%', 'type': 'DRUG', 'description': 'Once-daily application of tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.', 'armGroupLabels': ['Retin-A Micro Microsphere 0.1%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75006', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Stephens and Associates', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Ronald Gottschalk, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galderma R&D'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}