Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-25 @ 7:21 PM
Study NCT ID:
NCT00604032
Status:
COMPLETED
Last Update Posted:
2008-03-28
First Post:
2008-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Determine the Phototoxity of Atralin (Tretinoin) Gel, 0.05%
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014212', 'term': 'Tretinoin'}, {'id': 'D005782', 'term': 'Gels'}], 'ancestors': [{'id': 'D014801', 'term': 'Vitamin A'}, {'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-03-26', 'studyFirstSubmitDate': '2008-01-16', 'studyFirstSubmitQcDate': '2008-01-28', 'lastUpdatePostDateStruct': {'date': '2008-03-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'UV induced skin sensitization', 'timeFrame': '4 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Safety when exposed to sunlight'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To assess the potential of tretnoin gel 0.05% to produce phototoxic reactions, measured as skin reactions 24 and 48 hours after UV radiation of drug on skin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal healthy volunteers\n* 18 years of age or older\n\nExclusion Criteria:\n\n* Less than 18 years of age'}, 'identificationModule': {'nctId': 'NCT00604032', 'briefTitle': 'Study to Determine the Phototoxity of Atralin (Tretinoin) Gel, 0.05%', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coria Laboratories, Ltd.'}, 'officialTitle': 'Clinical Evaluation of the Phototoxic Potential of Atralin (Tretinoin) Gel, 0.05%', 'orgStudyIdInfo': {'id': '029-066-09-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: Atralin (tretinoin) Gel, 0.05%']}], 'interventions': [{'name': 'Atralin (tretinoin) Gel, 0.05%', 'type': 'DRUG', 'description': 'Assess potential of tretinoin gel, 0.05% to produce phototoxic reactions, measured 24 and 48 hours after UV radiation of drug on the skin.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27106', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Suncare Research Laboratories', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Joseph Stanfiled, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Suncare Laboratories'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coria Laboratories, Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'D. Cargill, PhD', 'oldOrganization': 'Coria Laboratories, Ltd.'}}}}