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

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

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.

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.

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