Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2026-01-04 @ 3:25 AM
Study NCT ID:
NCT01703793
Status:
COMPLETED
Last Update Posted:
2013-01-09
First Post:
2012-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study in Subjects With Seborrheic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012628', 'term': 'Dermatitis, Seborrheic'}], 'ancestors': [{'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-07', 'studyFirstSubmitDate': '2012-10-07', 'studyFirstSubmitQcDate': '2012-10-07', 'lastUpdatePostDateStruct': {'date': '2013-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom Improvement (investigator assessment)', 'timeFrame': 'Week 4', 'description': 'Proportion of subjects with a response of clear or almost clear, and at least a two-grade improvement from baseline to week 4'}], 'secondaryOutcomes': [{'measure': 'Symptom Improvement (subject assessment)', 'timeFrame': 'Weeks 2 and 4', 'description': 'Assess the change in the pruritus score from baseline to week 2 and to week 4.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Seborrheic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if two test products are safe and effective in the treatment of seborrheic dermatitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Investigator assessment of seborrheic dermatitis.\n* Additional criteria as identified in the protocol.\n\nExclusion Criteria:\n\n* History of or ongoing psoriasis of the scalp.\n* History of or ongoing atopic dermatitis of the scalp.\n* Additional criteria as identified in the protocol.'}, 'identificationModule': {'nctId': 'NCT01703793', 'briefTitle': 'Safety and Efficacy Study in Subjects With Seborrheic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medicis Global Service Corporation'}, 'officialTitle': 'A Parallel-group, Vehicle-controlled, Randomized, Double-blind Study of the Efficacy and Safety of Product 49778 and Product 10156 in Subjects With Seborrheic Dermatitis', 'orgStudyIdInfo': {'id': 'MP-1001-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'Vehicle (placebo) treatment, twice a week for four weeks.', 'interventionNames': ['Drug: Vehicle (placebo)']}, {'type': 'EXPERIMENTAL', 'label': 'Test Product 10156', 'description': 'Product 10156 treatment, twice a week for four weeks.', 'interventionNames': ['Drug: Test Product 10156']}, {'type': 'EXPERIMENTAL', 'label': 'Test Product 49778', 'description': 'Product 49778 treatment, twice a week for four weeks.', 'interventionNames': ['Drug: Test Product 49778']}], 'interventions': [{'name': 'Test Product 49778', 'type': 'DRUG', 'armGroupLabels': ['Test Product 49778']}, {'name': 'Test Product 10156', 'type': 'DRUG', 'armGroupLabels': ['Test Product 10156']}, {'name': 'Vehicle (placebo)', 'type': 'DRUG', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fremont', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'city': 'Snellville', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.85733, 'lon': -84.01991}}, {'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'city': 'Paramus', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.94454, 'lon': -74.07542}}, {'city': 'Mount Kisco', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 41.20426, 'lon': -73.72708}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}, {'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'city': 'Webster', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.53773, 'lon': -95.11826}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Ira Lawrence, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medicis Pharmaceutical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medicis Global Service Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}