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

• Status: Withdrawn
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Thesan Pharmaceuticals, Inc.

Criteria

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