Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2026-03-03 @ 2:20 AM
Study NCT ID:
NCT00621218
Status:
COMPLETED
Last Update Posted:
2008-12-18
First Post:
2008-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Determine the Safety and Efficacy of Atralin (Tretinoin 0.05%) Gel for the Treatment of Rosacea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012393', 'term': 'Rosacea'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-17', 'studyFirstSubmitDate': '2008-02-12', 'studyFirstSubmitQcDate': '2008-02-21', 'lastUpdatePostDateStruct': {'date': '2008-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in signs and symptoms of rosacea', 'timeFrame': '16 weeks'}], 'secondaryOutcomes': [{'measure': 'Changes in various skin parameters', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tretinoin, efficacy, safety, rosacea'], 'conditions': ['Rosacea']}, 'descriptionModule': {'briefSummary': 'To compare the efficacy and safety of tretinoin gel 0.05% to its vehicle when dosed once or twice daily in female subjects with rosacea.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Age 18-65\n* Diagnosed with classical, centrofacial, erythemato-telangiectatic rosacea\n\nExclusion Criteria:\n\n* Male, females less than 18 years\n* Females over 65 years\n* No diagnosed rosacea'}, 'identificationModule': {'nctId': 'NCT00621218', 'briefTitle': 'A Study to Determine the Safety and Efficacy of Atralin (Tretinoin 0.05%) Gel for the Treatment of Rosacea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coria Laboratories, Ltd.'}, 'officialTitle': 'A Pilot Study to Compare Tretinoin Gel, 0.05% to Tretinoin Gel Vehicle When Dosed Once or Twice Daily in Female Subjects With Classical Rosacea', 'orgStudyIdInfo': {'id': '9320-010-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: tretinoin gel 0.05%']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: vehicle']}], 'interventions': [{'name': 'tretinoin gel 0.05%', 'type': 'DRUG', 'description': 'Apply tretinoin gel, 0.05% topically once or twice daily to female subjects with rosacea', 'armGroupLabels': ['1']}, {'name': 'vehicle', 'type': 'DRUG', 'description': 'Apply Atralin Gel vehicle topically once or twice daily to female subjects with rosacea.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19428', 'city': 'Conshohocken', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Product Investigations, Inc.', 'geoPoint': {'lat': 40.07928, 'lon': -75.30157}}], 'overallOfficials': [{'name': 'Morris V Shelanski, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coria Laboratories, Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'D. Innes Cargill, PhD', 'oldOrganization': 'Coria Laboratories, Ltd.'}}}}