Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2026-02-27 @ 11:58 AM
Study NCT ID:
NCT01784133
Status:
COMPLETED
Last Update Posted:
2015-05-20
First Post:
2013-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Twelve Week Safety and Efficacy Study 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000625752', 'term': 'Omiganan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'dispFirstSubmitDate': '2015-05-01', 'lastUpdateSubmitDate': '2015-05-01', 'studyFirstSubmitDate': '2013-02-01', 'dispFirstSubmitQcDate': '2015-05-01', 'studyFirstSubmitQcDate': '2013-02-04', 'dispFirstPostDateStruct': {'date': '2015-05-20', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in inflammatory lesion count', 'timeFrame': '0, 1, 3, 6, 9 and 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Success on IGA defined as clear or almost clear', 'timeFrame': 'Week 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['rosacea'], 'conditions': ['Papulopustular Rosacea']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate th safety and efficacy of one-daily topical application of CLS001 low, mid and high dose compared to vehicle gel in subjects with papulopustular rosacea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of papulopustular rosacea (at least 15 lesions)\n\nExclusion Criteria:\n\n* nodular rosacea or subtype 3\n* clinically significant abnormal findings that would interfere with study objectives'}, 'identificationModule': {'nctId': 'NCT01784133', 'briefTitle': 'A Twelve Week Safety and Efficacy Study in Rosacea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Maruho Co., Ltd.'}, 'officialTitle': 'A Phase 2, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Three Once-Daily CLS001 Topical Gels Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea', 'orgStudyIdInfo': {'id': 'CLS001-CO-PR-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'omiganan mid dose', 'description': 'omiganan mid dose once daily application for 12 weeks', 'interventionNames': ['Drug: omiganan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'omiganan high dose', 'description': 'omiganan high dose once daily application for 12 weeks', 'interventionNames': ['Drug: omiganan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle group', 'description': 'Vehicle once daily application for 12 weeks', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'omiganan low dose', 'description': 'omiganan low dose once daily application for 12 weeks', 'interventionNames': ['Drug: omiganan']}], 'interventions': [{'name': 'omiganan', 'type': 'DRUG', 'armGroupLabels': ['omiganan high dose', 'omiganan low dose', 'omiganan mid dose']}, {'name': 'placebo', 'type': 'DRUG', 'armGroupLabels': ['Vehicle group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Radiant Research Inc.', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'ATS Clinical Research', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'The Savin Center, PC', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Skin Care Research, Inc', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '34698', 'city': 'Dunedin', 'state': 'Florida', 'country': 'United States', 'facility': 'Dunedin Research Specialists', 'geoPoint': {'lat': 28.0199, 'lon': -82.77323}}, {'zip': '32204', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'North Florida Dermatology Associates', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Dawes Fretzin Clinical Research Group', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '48088', 'city': 'Warren', 'state': 'Michigan', 'country': 'United States', 'facility': 'Grekin Skin Institute', 'geoPoint': {'lat': 42.49044, 'lon': -83.01304}}, {'zip': '14625', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester General Medical Group Center for Dermatology at Linden Oaks', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '11790', 'city': 'Stoney Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Derm Research Center of NY Inc.'}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Resarch', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Dermatology and Research Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '37674', 'city': 'Johnson City', 'state': 'Tennessee', 'country': 'United States', 'facility': 'TriCities Skin and Cancer', 'geoPoint': {'lat': 36.31344, 'lon': -82.35347}}, {'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Clinical Research Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Progressive Clinical Research, PA', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84117', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Dermatology Research Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Clinical Research Inc.', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maruho Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}