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

Completed · Phase 3

Conditions studied: Acne Vulgaris

In brief

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)

Key facts

Study ID

NCT03271021

Run by

Vyne Therapeutics Inc.

People needed

1488

Starts

2017-07-17

Expected to finish

2018-09-04

Last updated by the study team

2022-01-18

Who can join

Age: 9 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Foamix Investigational Site #395 — Tucson, Arizona, United States
• Foamix Investigational Site #315 — Bryant, Arkansas, United States
• Foamix Investigational Site #340 — Fort Smith, Arkansas, United States
• Foamix Investigational SIte #377 — Little Rock, Arkansas, United States
• Foamix Investigational Site #366 — Encino, California, United States
• Foamix Investigational Site #403 — Los Angeles, California, United States
• Foamix Investigational Site #303 — Murrieta, California, United States
• Foamix Investigational Site #369 — Northridge, California, United States
• Foamix Investigational Site #387 — Palm Springs, California, United States
• Foamix Investigational Site #393 — Pasadena, California, United States
• Foamix Investigational Site #380 — Poway, California, United States
• Foamix Investigational Site # 328 — Sacramento, California, United States
• Foamix Investigational Site #313 — San Diego, California, United States
• Foamix Investigational Site #336 — San Luis Obispo, California, United States
• Foamix Investigational Site #309 — Santa Ana, California, United States
• Foamix Investigational Site #325 — Santa Monica, California, United States
• Foamix Investigational Site #375 — Temecula, California, United States
• Foamix Investigational Site #381 — Aventura, Florida, United States
• Foamix Investigational SIte #371 — Boca Raton, Florida, United States
• Foamix Investigational Site #311 — Boca Raton, Florida, United States
• Foamix Investigational Site #398 — Brandon, Florida, United States
• Foamix Investigational Site #329 — Clearwater, Florida, United States
• Foamix Investigational Site #378 — Davie, Florida, United States
• Foamix Investigational Site #396 — DeLand, Florida, United States
• Foamix Investigational Site #376 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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