Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-03-05 @ 6:03 PM
Study NCT ID:
NCT02932267
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2016-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Subject Reported Outcomes With Use of Adapalene 0.3% - Benzoyl Peroxide (BPO) 2.5% in Dark Skin Acne
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068816', 'term': 'Adapalene'}, {'id': 'D005782', 'term': 'Gels'}, {'id': 'D000068801', 'term': 'Adapalene, Benzoyl Peroxide Drug Combination'}], 'ancestors': [{'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D001585', 'term': 'Benzoyl Peroxide'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D004338', 'term': 'Drug Combinations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rajeev.chavda@galderma.com', 'phone': '0033', 'title': 'Rajeev Chavda', 'phoneExt': '492382928', 'organization': 'Galderma'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 16 Weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Adapalene / BPO Gel', 'description': 'Adapalene 0.3% / BPO 2.5% gel, once daily in the evening\n\nAdapalene 0.3% / BPO 2.5% gel: Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 9, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Post inflammatory pigmentation change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Subject 's Overall Satisfaction With Study Treatment Via a Satisfaction Questionnaire", 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adapalene / BPO Gel', 'description': 'Adapalene 0.3% / BPO 2.5% gel, once daily in the evening\n\nAdapalene 0.3% / BPO 2.5% gel: Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At week 12', 'description': '% of subjects satisfied to very satisfied with study treatment at week 12', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat (ITT) population. Here 'N' (number analyzed) signifies number of participants evaluable for this outcome measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adapalene / BPO Gel', 'description': 'Adapalene 0.3% / BPO 2.5% gel, once daily in the evening\n\nAdapalene 0.3% / BPO 2.5% gel: Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Wash-out period for topical treatment or procedures of 1 week to 3 months and for systemic treatment for 1 month to 3 months, depending on treatment'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Adapalene / BPO Gel', 'description': 'Adapalene 0.3% / BPO 2.5% gel, once daily in the evening\n\nAdapalene 0.3% / BPO 2.5% gel: Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.9', 'spread': '6.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Latin American', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Black/African-American', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Singapore', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'Mauritius', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Skin phototype', 'classes': [{'categories': [{'title': 'Phototype IV', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': 'Phototype V', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Phototype VI', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Fitzpatrick skin phototype is a system used to describe a person's skin type. It ranges from skin phototype I to VI. Where, skin phototype I = pale white skin, always burns easily, never tans; skin phototype II = fair skin, always burns easily, tans minimally and with difficulty; skin phototype III = darker white skin, burns minimally, tans gradually and uniformly; skin phototype IV = light brown skin, burns minimally, always tans well; skin phototype V = brown skin, rarely burns, tans profusely; skin phototype VI = dark brown or black skin, never burns, tans profusely.", 'unitOfMeasure': 'Participants'}], 'populationDescription': 'ITT population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-23', 'size': 1552763, 'label': 'Study Protocol and Statistical Analysis Plan: Version for USA', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-10-31T07:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-16', 'studyFirstSubmitDate': '2016-10-11', 'resultsFirstSubmitDate': '2018-09-26', 'studyFirstSubmitQcDate': '2016-10-12', 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-11', 'studyFirstPostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Subject 's Overall Satisfaction With Study Treatment Via a Satisfaction Questionnaire", 'timeFrame': 'At week 12', 'description': '% of subjects satisfied to very satisfied with study treatment at week 12'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acne', 'Dark skin'], 'conditions': ['Acne Vulgaris']}, 'referencesModule': {'references': [{'pmid': '31251543', 'type': 'DERIVED', 'citation': 'DuBois J, Ong GCW, Petkar G, Almeida LMC, Chavda R, Kerrouche N, Alexis AF. Patient-Reported Outcomes in Acne Patients With Skin of Color Using Adapalene 0.3%-Benzoyl Peroxide 2.5%: A Prospective Real-World Study. J Drugs Dermatol. 2019 Jun 1;18(5):514.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter open-label, prospective study in subjects with dark skin from one of the 3 ethnic/race backgrounds: Asian, Latin American and Black/African-American and with moderate to severe acne vulgaris on the face.\n\nAll eligible subjects will receive Adapalene 0.3% - BPO 2.5% gel (Epiduo Forte/TactuPump Forte) once daily on whole face.\n\nThe purpose of this trial is to evaluate subject reported outcomes with the combination of Adapalene 0.3% - BPO 2.5%, Epiduo Forte / TactuPump Forte gel, after 16 weeks of treatment of moderate to severe acne in dark skin phototypes (IV to VI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject with clinical diagnosis of moderate to severe facial acne vulgaris, defined by:\n\n 1. Investigator's Global Assessment (IGA) score of 3 (Moderate) OR 4 (Severe ); and\n 2. A minimum of 25-100 inflammatory lesions (papules and pustules); and\n 3. A minimum of 30-150 non-inflammatory lesions (open and closed comedones) in total (excluding the nose); and\n 4. No more than two acne nodules (≥ 1 cm),\n* Subject with skin phototype IV to VI on Fitzpatrick skin phototype scale,\n* Subjects from one of the 3 ethnic/race backgrounds: Asian, Latin American and Black/African-American,\n\nExclusion Criteria:\n\n* Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, acne requiring systemic treatment,\n* Subject with history of lupus, atopic dermatitis, perioral dermatitis, dermatomyositis, rosacea\n* Female subject who is pregnant, lactating or planning a pregnancy during the trial,\n* Subjects having received at least one of the following topical treatments on the treated area: Corticosteroids, antibiotics, benzoyl peroxide, azelaic acid, dapsone, hydroxyacids, Zinc containing treatments, antiseptics, other anti-inflammatory products or other acne treatments (2 weeks); Retinoids (4 weeks); Cosmetic/aesthetic procedures on the face (1 week); Wax epilation (2 weeks); Photodynamic therapy (6 weeks); Laser therapy, microdermabrasion, deep chemical peel, plastic surgery for acne (3 months).\n* Subjects having received at least one of the following systemic treatments: Corticosteroids, tetracyclines, other antibiotics (except penicillin) (1 month); Oral retinoids/isotretinoin/ anti-androgens / Cyproterone acetate / Chlormadinone acetate (6 months); Spironolactone/ Drospirenone (3 months); Immunomodulators (3 months) and Oral contraceptives/ oral dapsone for acne(1 month)."}, 'identificationModule': {'nctId': 'NCT02932267', 'acronym': 'EDeN', 'briefTitle': 'Subject Reported Outcomes With Use of Adapalene 0.3% - Benzoyl Peroxide (BPO) 2.5% in Dark Skin Acne', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'Subject Reported Outcomes With Use of Adapalene 0.3% - Benzoyl Peroxide 2.5% in Moderate to Severe Acne in Dark Skin Phototype Subjects', 'orgStudyIdInfo': {'id': 'RD.03.SPR.110232'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adapalene / BPO gel', 'description': 'Adapalene 0.3% / BPO 2.5% gel, once daily in the evening', 'interventionNames': ['Drug: Adapalene 0.3% / BPO 2.5% gel']}], 'interventions': [{'name': 'Adapalene 0.3% / BPO 2.5% gel', 'type': 'DRUG', 'otherNames': ['Epiduo Forte / Tactupump gel'], 'description': 'Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks', 'armGroupLabels': ['Adapalene / BPO gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Dermresearch', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Phoenix', 'country': 'Mauritius', 'facility': 'CIDP', 'geoPoint': {'lat': -20.28667, 'lon': 57.50222}}, {'city': 'Singapore', 'country': 'Singapore', 'facility': 'CIDP', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}