Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris
Lead Sponsor:
Vyne Therapeutics Inc.
Conditions:
Acne Vulgaris
Eligibility:
All Genders
9+ years
Phase:
PHASE3
Brief 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 FX...
Detailed Description
This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy over 12 weeks of FMX101 topical foam containing 4% minocycline compared to vehicle ...
Eligibility Criteria
Inclusion
- Has facial acne vulgaris with:
- 20 to 50 inflammatory lesions (papules, pustules, and nodules)
- 25 to 100 non-inflammatory lesions (open and closed comedones)
- No more than 2 nodules on the face
- IGA score of moderate (3) to severe (4)
- 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
- 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.
- Sunburn on the face.
Key Trial Info
Start Date :
July 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2018
Estimated Enrollment :
1488 Patients enrolled
Trial Details
Trial ID
NCT03271021
Start Date
July 17 2017
End Date
September 4 2018
Last Update
January 18 2022
Active Locations (98)
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1
Foamix Investigational Site #376
Phoenix, Arizona, United States, 85023
2
Foamix Investigational Site #395
Tucson, Arizona, United States, 85712
3
Foamix Investigational Site #315
Bryant, Arkansas, United States, 72022
4
Foamix Investigational Site #340
Fort Smith, Arkansas, United States, 72916