Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2026-03-25 @ 4:25 PM
Study NCT ID:
NCT01815450
Status:
COMPLETED
Last Update Posted:
2015-02-02
First Post:
2013-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BLI1100-202: BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 369}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'dispFirstSubmitDate': '2015-01-26', 'lastUpdateSubmitDate': '2015-01-26', 'studyFirstSubmitDate': '2013-03-18', 'dispFirstSubmitQcDate': '2015-01-26', 'studyFirstSubmitQcDate': '2013-03-20', 'dispFirstPostDateStruct': {'date': '2015-02-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in total lesion count', 'timeFrame': 'Baseline to Week 12'}], 'secondaryOutcomes': [{'measure': 'Percent change in total lesion count', 'timeFrame': 'Baseline to Week 12'}, {'measure': "Investigator's Global Assessment", 'timeFrame': '12 weeks', 'description': 'Rating of overall facial acne on a 5 point scale (0=clear, 4 = severe)'}, {'measure': 'Local Tolerability Score', 'timeFrame': '12 weeks', 'description': 'Rating of facial symptoms on a 4 point scale (0=none, 3=severe)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the safety and efficacy of BLI1100 formulations to placebo for the treatment of moderate to severe acne vulgaris.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males or females 12 to 45 years of age with facial acne vulgaris\n* Qualifying Investigator's Global Assessment severity score\n* Qualifying number of non-inflammatory lesions\n* Qualifying number of inflammatory lesions\n\nExclusion Criteria:\n\n* Facial hair (beard), excessive scarring, sunburn or other disfigurement that may obscure the accurate assessment of acne grade\n* Using medications that are reported to exacerbate acne\n* Any clinically relevant finding at their baseline physical examination or dermatological medical history such as severe systemic diseases or diseases of the facial skin\n* Have a known hypersensitivity or previous allergic reaction to any of the components\n* Patients who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days\n* Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures"}, 'identificationModule': {'nctId': 'NCT01815450', 'briefTitle': 'BLI1100-202: BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris', 'organization': {'class': 'INDUSTRY', 'fullName': 'Braintree Laboratories'}, 'orgStudyIdInfo': {'id': 'BLI1100-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BLI1100', 'description': 'BLI1100 topical cream', 'interventionNames': ['Drug: BLI1100']}, {'type': 'EXPERIMENTAL', 'label': 'BLI1100 - modified formulation', 'description': 'BLI1100 topical cream', 'interventionNames': ['Drug: BLI1100 - modified formulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Topical cream', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BLI1100', 'type': 'DRUG', 'description': 'BLI1100 topical cream', 'armGroupLabels': ['BLI1100']}, {'name': 'BLI1100 - modified formulation', 'type': 'DRUG', 'description': 'BLI1100 topical cream', 'armGroupLabels': ['BLI1100 - modified formulation']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo topical cream', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Center for Dermatology Clincal Research', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '32204', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'North Florida Dermatology Associates', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Ameriderm Research', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'zip': '30327', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Peachtree Dermatology Associates Research Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46168', 'city': 'Plainfield', 'state': 'Indiana', 'country': 'United States', 'facility': 'The Indiana Clinical Trials Center', 'geoPoint': {'lat': 39.70421, 'lon': -86.39944}}, {'zip': '48706', 'city': 'Bay City', 'state': 'Michigan', 'country': 'United States', 'facility': 'Great Lakes Research Group, Inc.', 'geoPoint': {'lat': 43.59447, 'lon': -83.88886}}, {'zip': '55432', 'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Clinical Study Center', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Academic Dermatology Associates', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '02919', 'city': 'Johnston', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Clinical Partners', 'geoPoint': {'lat': 41.82186, 'lon': -71.50675}}, {'zip': '77802', 'city': 'Bryan', 'state': 'Texas', 'country': 'United States', 'facility': 'DiscoveResearch', 'geoPoint': {'lat': 30.67436, 'lon': -96.36996}}, {'zip': '77056', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Suzanne Bruce and Associates', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Dermatology Research Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '24501', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'The Education and Research Foundation', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Women's Clinical Research Center", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Premier Clinical Research', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'John McGowan, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Braintree Laboratories, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Braintree Laboratories', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}