A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris

• Status: Completed
• Trial end date: 2018-09-04
• Target enrollment: 0
• Participant gender: All

Summary

A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris (Study FX2017-22)

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

Details

• Lead Sponsor: Foamix Ltd.; Vyne Therapeutics Inc.
• Treatments: Minocycline

Criteria

Inclusion Criteria:

1. Has facial acne vulgaris with:

1. 20 to 50 inflammatory lesions (papules, pustules, and nodules)

2. 25 to 100 non-inflammatory lesions (open and closed comedones)

3. No more than 2 nodules on the face

4. IGA score of moderate (3) to severe (4)

2. Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin Cleanser) and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study.

Exclusion Criteria:

1. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations.

2. Sunburn on the face.