Efficacy and Safety Study of VB-1953 Topical Gel for Inflammatory Facial Acne Vulgaris

• Status: Unknown status
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Dose-ranging Study in the Treatment of Acne Vulgaris,

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vyome Therapeutics Inc.

Criteria

Inclusion Criteria:

• Males or non-pregnant females 9 to 45 years of age (inclusive) at the time of consent/assent.

• Have a clinical diagnosis of moderate to severe (Grade 3 or 4) facial acne vulgaris, as determined by the Investigator's Global Assessment (IGA).

• Have 20 to 50 inflammatory lesions (papules, pustules) on the face.

• Have 20 to 60 non-inflammatory lesions on the face.

Exclusion Criteria:

• Has more than two (2) facial nodulocystic lesions.

• Female subject is pregnant, lactating, or is planning to become pregnant during the study.

• Has active nodulocystic acne or acne conglobata, acne fulminans, or other forms of acne (e.g., acne mechanica). In the opinion of the Investigator, the subject has a skin pathology or other medical condition that is clinically significant (e.g., obesity) and will preclude participation in the study.

• Has presence of any skin condition on the face (e.g., rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acnetiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis) in the opinion of the Investigator that could interfere with the diagnosis or assessment of acne vulgaris or evaluation of the investigational product (IP) or requires the use of interfering topical or systemic therapy.

• Not willing to minimize or avoid natural and artificial sunlight exposure during treatment.