TSN2898-201 Safety and Efficacy of TSN2898 in the Treatment of Acne Vulgaris

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Vehicle
* Drug: TSN2898
* Drug: TSN2898
* Drug: TSN2898


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Vehicle<br>Vehicle gel | Drug: Vehicle<br>* Applied once a day<br>* Other names: Topical gel;|
| Experimental: Low Dose Active<br>Low Dose of TSN2898 | Drug: TSN2898<br>* Applied once a day<br>* Other names: Topical gel;|
| Experimental: Mid Dose Active<br>Mid Dose of TSN2898 | Drug: TSN2898<br>* Applied once a day<br>* Other names: Topical gel;|
| Experimental: High Dose Active<br>High Dose of TSN2898 | Drug: TSN2898<br>* Applied once a day<br>* Other names: Topical gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-inflammatory lesion counts | Absolute change from Baseline | 12 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne, topical, SCD-1 inhibitor, moderate, severe