A Study of S6G5T 3 in the Treatment of Acne Vulgaris

• Status: Completed
• Trial end date: 2019-12-11
• Target enrollment: 0
• Participant gender: All

Summary

To assess the efficacy of S6G5T-3 compared to its Vehicle when applied once daily for 12 weeks in Patients with acne vulgaris

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sol-Gel Technologies, Ltd.

Criteria

Inclusion Criteria:

1. Patient must sign an Institutional Review Board (IRB) approved written informed consent for this study.

2. Male and female 9 years of age and older.

3. Have two (2) or fewer cysts or nodules

Exclusion Criteria:

1. More than two acne nodules or cysts (defined as an inflammatory lesion greater than or equal to 5 mm in diameter).

2. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)

3. History of blood dyscrasia (e.g., leukemia, haemophilia, sickle cell anemia, multiple myeloma, etc.)

4. Underlying disease that requires the use of interfering topical or systemic therapy.

5. Other dermatological conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis, or rosacea.