Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-02-17 @ 7:40 PM
Study NCT ID:
NCT01740934
Status:
COMPLETED
Last Update Posted:
2015-11-02
First Post:
2012-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability, and Effects of Anatabloc® Crème in 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-29', 'studyFirstSubmitDate': '2012-11-30', 'studyFirstSubmitQcDate': '2012-11-30', 'lastUpdatePostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Effects', 'timeFrame': '8 to 16 weeks', 'description': 'Collected information of the safety, tolerability and adverse events, and subjective experience related to the use of Anatabloc Cream by subjects'}], 'secondaryOutcomes': [{'measure': 'Change in the appearance of the facial skin', 'timeFrame': '8 to 16 weeks', 'description': 'Change measured by comparison of questionnaire and rating scores over time'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['rosacea', 'anatabine', 'Anatabloc', 'dermatology'], 'conditions': ['Rosacea']}, 'descriptionModule': {'briefSummary': 'This is a multi-site, four-visit, eight-week, double-blind, randomized, vehicle-controlled, parallel-group study followed by an eight-week open-label extension to evaluate the safety, tolerability, and potential effects of Anatabloc Facial Cream. The secondary aim is to evaluate if Anatabloc Facial Cream improves the appearance of the skin in subjects with mild to moderate rosacea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 25-70 years\n* diagnosed with mild to moderate rosacea\n\nExclusion Criteria:\n\n* allergy or sensitivity to the study products or their components\n* severe rosacea\n* current use of glucocorticoids, anti-acne products, antibiotics, topical retinoids, or vasoactive drugs\n* recent oral isotretinoin use\n* current use of anatabine-containing supplements (ie. Anatabloc, Anatabloc Unflavored, CigRx)'}, 'identificationModule': {'nctId': 'NCT01740934', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability, and Effects of Anatabloc® Crème in Rosacea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rock Creek Pharmaceuticals, Inc.'}, 'officialTitle': 'An Eight-Week, Multi-Site, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Trial to Evaluate the Safety, Tolerability, and Effects of Anatabloc® Crème in Subjects With Rosacea Followed by an Open-Label Extension', 'orgStudyIdInfo': {'id': 'RCP-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Anatabloc Cream', 'description': 'Twice daily use of active facial cream', 'interventionNames': ['Other: Anatabloc Cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Cream', 'description': 'Twice daily use of placebo facial cream', 'interventionNames': ['Other: Placebo Cream']}], 'interventions': [{'name': 'Anatabloc Cream', 'type': 'OTHER', 'description': 'subject will apply active cream topically, twice per day according to instructions', 'armGroupLabels': ['Anatabloc Cream']}, {'name': 'Placebo Cream', 'type': 'OTHER', 'description': 'subject will apply placebo cream topically, twice per day according to instructions', 'armGroupLabels': ['Placebo Cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34209', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Susan H. Weinkle, MD', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '70124', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Lupo Center for Aesthetic & General Dermatology', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '10022', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Diane Berson, MD', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'M Varga, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Star Scientific'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rock Creek Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}