Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-04-19 @ 2:56 AM
Study NCT ID:
NCT02796066
Status:
WITHDRAWN
Last Update Posted:
2017-04-26
First Post:
2016-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TSN2898-201 Safety and Efficacy of TSN2898 in the Treatment of Acne Vulgaris
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}], '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'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005782', 'term': 'Gels'}], 'ancestors': [{'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Protocol not approved', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-24', 'studyFirstSubmitDate': '2016-05-26', 'studyFirstSubmitQcDate': '2016-06-06', 'lastUpdatePostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Non-inflammatory lesion counts', 'timeFrame': '12 weeks', 'description': 'Absolute change from Baseline'}, {'measure': 'Absolute change from Baseline for inflammatory plus non-inflammatory lesions', 'timeFrame': '12 weeks'}, {'measure': 'Percent change from Baseline for inflammatory and non-inflammatory lesions', 'timeFrame': '12 weeks'}, {'measure': "Investigator's Global Assessment of Acne Severity Score (IGA)", 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acne, topical, SCD-1 inhibitor, moderate, severe'], 'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and effectiveness of TSN 2898 topical gel in the treatment of moderate to severe acne.', 'detailedDescription': 'TSN2898 is an inhibitor of stearoyl-CoA desaturase-1 (SCD-1), an enzyme present in sebaceous glands and a key regulatory enzyme in lipogenesis. This study will assess the safety and efficacy of TSN2898 topical gel and matched gel vehicle, applied daily on the face for the treatment of moderate to severe acne vulgaris.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males or females, 16 to 55 years of age\n* Must be diagnosed as having moderate or severe acne vulgaris\n* ≥ 20 inflammatory lesions on the face\n* ≥ 20 non-inflammatory lesions on the face\n* ≤ 3 nodule/cyst acne lesions\n* Medically healthy\n* Females must be of non-childbearing potential\n\nExclusion Criteria:\n\n* Systemic therapy with retinoids within six (6) months prior to study start\n* Topical use of prescription retinoids within four (4) weeks prior to study start\n* Oral antibiotics within four (4) weeks prior to study start\n* Topical dapsone, sulfacetamide, benzoyl peroxide, α-hydroxy/glycolic acid and retinol/retinaldehyde-containing products, and topical antibiotics, anti-inflammatory medications and corticosteroids on the face within two (2) weeks prior to study start\n* Facial procedures, including lasers, peels, and dermabrasion, within two (2) months prior to study start'}, 'identificationModule': {'nctId': 'NCT02796066', 'briefTitle': 'TSN2898-201 Safety and Efficacy of TSN2898 in the Treatment of Acne Vulgaris', 'organization': {'class': 'INDUSTRY', 'fullName': 'Thesan Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of TSN2898 Topical Gel for the Treatment of Acne Vulgaris', 'orgStudyIdInfo': {'id': 'TSN2898-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'Vehicle gel', 'interventionNames': ['Drug: Vehicle']}, {'type': 'EXPERIMENTAL', 'label': 'Low Dose Active', 'description': 'Low Dose of TSN2898', 'interventionNames': ['Drug: TSN2898']}, {'type': 'EXPERIMENTAL', 'label': 'Mid Dose Active', 'description': 'Mid Dose of TSN2898', 'interventionNames': ['Drug: TSN2898']}, {'type': 'EXPERIMENTAL', 'label': 'High Dose Active', 'description': 'High Dose of TSN2898', 'interventionNames': ['Drug: TSN2898']}], 'interventions': [{'name': 'Vehicle', 'type': 'DRUG', 'otherNames': ['Topical gel'], 'description': 'Applied once a day', 'armGroupLabels': ['Vehicle']}, {'name': 'TSN2898', 'type': 'DRUG', 'otherNames': ['Topical gel'], 'description': 'Applied once a day', 'armGroupLabels': ['Low Dose Active']}, {'name': 'TSN2898', 'type': 'DRUG', 'otherNames': ['Topical gel'], 'description': 'Applied once a day', 'armGroupLabels': ['Mid Dose Active']}, {'name': 'TSN2898', 'type': 'DRUG', 'otherNames': ['Topical gel'], 'description': 'Applied once a day', 'armGroupLabels': ['High Dose Active']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Thesan Site 4', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Thesan Site 3', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '27626', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Thesan Site 6', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '02919', 'city': 'Johnston', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Thesan Site 5', 'geoPoint': {'lat': 41.82186, 'lon': -71.50675}}, {'city': 'Santo Domingo', 'country': 'Dominican Republic', 'facility': 'Thesan Site 2', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}, {'city': 'San Pedro Sula', 'country': 'Honduras', 'facility': 'Thesan Site 1', 'geoPoint': {'lat': 15.50585, 'lon': -88.02588}}], 'overallOfficials': [{'name': 'Howard Welgus, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Thesan Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thesan Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}