Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2026-03-01 @ 4:13 PM
Study NCT ID:
NCT01425320
Status:
WITHDRAWN
Last Update Posted:
2012-11-19
First Post:
2011-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics Study of Dapsone-Adapalene Fixed Combination Gel in Acne
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'}, {'id': 'D005782', 'term': 'Gels'}, {'id': 'D000068816', 'term': 'Adapalene'}], 'ancestors': [{'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'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': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study was never initiated due to company decision. No study subjects were ever enrolled or dosed.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-11-16', 'studyFirstSubmitDate': '2011-08-26', 'studyFirstSubmitQcDate': '2011-08-26', 'lastUpdatePostDateStruct': {'date': '2012-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Levels of Dapsone', 'timeFrame': 'Day 1'}, {'measure': 'Plasma Levels of Dapsone', 'timeFrame': 'Day 14'}, {'measure': 'Plasma Levels of Adapalene', 'timeFrame': 'Day 1'}, {'measure': 'Plasma Levels of Adapalene', 'timeFrame': 'Day 14'}], 'secondaryOutcomes': [{'measure': 'Local Dermal Tolerability Rating Using a 4-Point Scale', 'timeFrame': 'Day 14'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'This study will investigate the pharmacokinetics, safety and tolerability of dapsone and adapalene following topical administration of 2 formulations of dapsone/adapalene fixed combination gel, dapsone 5% gel (ACZONE®), and adapalene 0.3% gel (Differin®) in subjects with acne vulgaris.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate acne on the face\n* Willing to avoid swimming during the study\n* Willing to avoid excessive sunlight and ultraviolet light (e.g., tanning beds)during the study\n* Willing to avoid moisturizers, sunscreens, cosmetics, and chemical peels during the study\n\nExclusion Criteria:\n\n* Severe cystic acne\n* Use of topical or oral retinoids within 4 weeks\n* Use of isotretinoin within 3 months\n* Use of dapsone or adapalene within 3 months\n* Anticipated need to engage in activities/exercise that would cause profuse sweating\n* Donated blood or equivalent blood loss within 90 days'}, 'identificationModule': {'nctId': 'NCT01425320', 'briefTitle': 'Pharmacokinetics Study of Dapsone-Adapalene Fixed Combination Gel in Acne', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': '225678-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fixed Combination dapsone/adapalene Formulation A Gel', 'description': 'Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.', 'interventionNames': ['Drug: Fixed Combination dapsone/adapalene Formulation A Gel']}, {'type': 'EXPERIMENTAL', 'label': 'Fixed Combination dapsone/adapalene Formulation B Gel', 'description': 'Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.', 'interventionNames': ['Drug: Fixed Combination dapsone/adapalene Formulation B Gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dapsone 5% gel (ACZONE®)', 'description': 'Study medication will be applied twice daily for 14 days to the face, upper chest, upper back, and shoulders.', 'interventionNames': ['Drug: dapsone 5% gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'adapalene 0.3% gel (Differin®)', 'description': 'Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.', 'interventionNames': ['Drug: adapalene 0.3% gel']}], 'interventions': [{'name': 'Fixed Combination dapsone/adapalene Formulation A Gel', 'type': 'DRUG', 'description': 'Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.', 'armGroupLabels': ['Fixed Combination dapsone/adapalene Formulation A Gel']}, {'name': 'Fixed Combination dapsone/adapalene Formulation B Gel', 'type': 'DRUG', 'description': 'Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.', 'armGroupLabels': ['Fixed Combination dapsone/adapalene Formulation B Gel']}, {'name': 'dapsone 5% gel', 'type': 'DRUG', 'otherNames': ['ACZONE®'], 'description': 'Study medication will be applied twice daily for 14 days to the face, upper chest, upper back, and shoulders.', 'armGroupLabels': ['dapsone 5% gel (ACZONE®)']}, {'name': 'adapalene 0.3% gel', 'type': 'DRUG', 'otherNames': ['Differin®'], 'description': 'Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.', 'armGroupLabels': ['adapalene 0.3% gel (Differin®)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}