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

Thesan Pharmaceuticals

Status and phase: Withdrawn; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: TSN2898; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT02796066

TSN2898-201

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 16 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 4 patient groups, including a placebo group

Vehicle

Placebo Comparator group

Description:

Vehicle gel

Treatment:

Drug: Vehicle

Low Dose Active

Experimental group

Description:

Low Dose of TSN2898

Treatment:

Drug: TSN2898

Mid Dose Active

Experimental group

Description:

Mid Dose of TSN2898

Treatment:

Drug: TSN2898

High Dose Active

Experimental group

Description:

High Dose of TSN2898

Treatment:

Drug: TSN2898