TSN2898-201 Safety and Efficacy of TSN2898 in the Treatment of Acne Vulgaris
- Registration Number
- NCT02796066
- Lead Sponsor
- Thesan Pharmaceuticals, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Healthy males or females, 16 to 55 years of age
- Must be diagnosed as having moderate or severe acne vulgaris
- ≥ 20 inflammatory lesions on the face
- ≥ 20 non-inflammatory lesions on the face
- ≤ 3 nodule/cyst acne lesions
- Medically healthy
- Females must be of non-childbearing potential
- Systemic therapy with retinoids within six (6) months prior to study start
- Topical use of prescription retinoids within four (4) weeks prior to study start
- Oral antibiotics within four (4) weeks prior to study start
- 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
- Facial procedures, including lasers, peels, and dermabrasion, within two (2) months prior to study start
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle Vehicle Vehicle gel Low Dose Active TSN2898 Low Dose of TSN2898 Mid Dose Active TSN2898 Mid Dose of TSN2898 High Dose Active TSN2898 High Dose of TSN2898
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) 12 weeks
- Secondary Outcome Measures
Name Time Method Non-inflammatory lesion counts 12 weeks Absolute change from Baseline
Absolute change from Baseline for inflammatory plus non-inflammatory lesions 12 weeks Percent change from Baseline for inflammatory and non-inflammatory lesions 12 weeks Investigator's Global Assessment of Acne Severity Score (IGA) 12 weeks
Trial Locations
- Locations (6)
Thesan Site 2
🇩🇴Santo Domingo, Dominican Republic
Thesan Site 5
🇺🇸Johnston, Rhode Island, United States
Thesan Site 6
🇺🇸High Point, North Carolina, United States
Thesan Site 1
🇭🇳San Pedro Sula, Honduras
Thesan Site 3
🇺🇸Miami, Florida, United States
Thesan Site 4
🇺🇸San Diego, California, United States