Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-01-05 @ 12:29 AM
Study NCT ID:
NCT03132194
Status:
COMPLETED
Last Update Posted:
2017-05-04
First Post:
2017-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing Test to Aczone 7.5% and Both to a Placebo Control in the 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': 'D003622', 'term': 'Dapsone'}], 'ancestors': [{'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-03', 'studyFirstSubmitDate': '2017-03-16', 'studyFirstSubmitQcDate': '2017-04-26', 'lastUpdatePostDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in inflammatory lesion counts', 'timeFrame': '12 weeks', 'description': 'Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts'}, {'measure': 'Change in non-inflammatory lesion counts', 'timeFrame': '12 weeks', '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': '12 weeks', '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': 'To evaluate the therapeutic effect of DPSG and Placebo gel in the treatment of acne vulgaris.', 'detailedDescription': 'A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group study comparing DPSG to ACZONE Gel and active treatment to a Placebo control in the treatment of Acne Vulgaris.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or non pregnant female aged ≥ 12 years 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': 'NCT03132194', 'briefTitle': 'Study Comparing Test to Aczone 7.5% and Both to a Placebo Control in the Treatment of Acne Vulgaris', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sun Pharmaceutical Industries, Inc.'}, 'officialTitle': 'A Single-center, Double-blind, Randomized, Parallel-group Study, Comparing DPSG to a Placebo Control in the Treatment of Acne Vulgaris', 'orgStudyIdInfo': {'id': 'DPSG-1517'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DPSG 7.5%', 'description': 'DPSG 7.5% (Taro Pharmaceuticals USA)\n\nTopical, twice daily on the face for 84 days.', 'interventionNames': ['Drug: DPSG 7.5%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Gel', 'description': 'Placebo product (Taro Pharmaceuticals Inc.)\n\nTopical, twice daily on the face for 84 days.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aczone', 'description': 'dapsone 7.5\n\nTopical, twice daily on the face for 84 days.', 'interventionNames': ['Drug: Aczone']}], 'interventions': [{'name': 'DPSG 7.5%', 'type': 'DRUG', 'otherNames': ['dapsone'], 'description': 'topical gel', 'armGroupLabels': ['DPSG 7.5%']}, {'name': 'Aczone', 'type': 'DRUG', 'otherNames': ['dapsone'], 'description': 'topical gel', 'armGroupLabels': ['Aczone']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Vehicle'], 'description': 'topical gel', 'armGroupLabels': ['Vehicle Gel']}]}, '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'}}}}