Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-03-05 @ 4:55 PM
Study NCT ID:
NCT02709902
Status:
COMPLETED
Last Update Posted:
2017-05-04
First Post:
2016-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing Adapalene/BP Gel to EPIDUO® FORTE and Both to a Placebo Control in Treatment of Acne Vulgaris
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 'D000068801', 'term': 'Adapalene, Benzoyl Peroxide Drug Combination'}], 'ancestors': [{'id': 'D001585', 'term': 'Benzoyl Peroxide'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000068816', 'term': 'Adapalene'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 460}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-03', 'studyFirstSubmitDate': '2016-03-08', 'studyFirstSubmitQcDate': '2016-03-15', 'lastUpdatePostDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in inflammatory lesion counts', 'timeFrame': 'Week 12', 'description': 'Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts'}, {'measure': 'Change in non-inflammatory lesion counts', 'timeFrame': 'Week 12', 'description': 'Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts'}], 'secondaryOutcomes': [{'measure': 'Clinical response of success', 'timeFrame': 'Week 12', 'description': "The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'Bioequivalence with Clinical Endpoints.', 'detailedDescription': 'Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design, Bioequivalence with Clinical Endpoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or non pregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis of acne vulgaris.\n\nExclusion Criteria:\n\n* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation'}, 'identificationModule': {'nctId': 'NCT02709902', 'briefTitle': 'Study Comparing Adapalene/BP Gel to EPIDUO® FORTE and Both to a Placebo Control in Treatment of Acne Vulgaris', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sun Pharmaceutical Industries, Inc.'}, 'officialTitle': 'A Multi-center, Double-blind, Randomized, Placebo, Controlled, Parallel-group Study, Comparing Adapalene/BP Gel, 0.3%/2.5% to EPIDUO® FORTE GEL and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris', 'orgStudyIdInfo': {'id': 'ADBG 1519'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adapalene/BP gel, 0.3%/2.5%', 'description': 'Topical, once daily, for 84 days.', 'interventionNames': ['Drug: Adapalene/BP gel, 0.3%/2.5%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EPIDUO® FORTE', 'description': 'Topical, once daily, for 84 days.', 'interventionNames': ['Drug: EPIDUO® FORTE']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Topical, once daily, for 84 days.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Adapalene/BP gel, 0.3%/2.5%', 'type': 'DRUG', 'otherNames': ['Adapalene, benzoyl peroxide'], 'description': 'Gel', 'armGroupLabels': ['Adapalene/BP gel, 0.3%/2.5%']}, {'name': 'EPIDUO® FORTE', 'type': 'DRUG', 'otherNames': ['Adapalene, benzoyl peroxide'], 'description': 'Gel', 'armGroupLabels': ['EPIDUO® FORTE']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Vehicle'], 'description': 'Gel', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Catawba Research', 'role': 'STUDY_CHAIR', 'affiliation': 'http://catawbaresearch.com/contact/'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Pharmaceutical Industries, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}