A Study (Study 1) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea

Completed · Phase 3

Conditions studied: Facial Papulopustular Rosacea

In brief

The primary objectives of this study are to determine the efficacy and safety of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea.

Key facts

Study ID

NCT03142451

Run by

Vyne Therapeutics Inc.

People needed

751

Starts

2017-06-02

Expected to finish

2018-09-28

Last updated by the study team

2021-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Moderate-to-severe rosacea (as per the IGA score) on the proposed facial treatment area consisting of:
• At least 15 and not more than 75 facial papules and pustules, excluding lesions involving the eyes and scalp;
• No more than 2 nodules on the face.
• Presence of or history of erythema and/or flushing on the face.

You may not qualify if…

• Presence of any skin condition and/or Excessive facial hair, on the face that would interfere with the diagnosis or assessment of rosacea.
• Moderate or severe rhinophyma, dense telangiectasia (score 3, severe), or plaque-like facial edema.
• History of hypersensitivity or allergy to minocycline, any other tetracycline, or of any other component of the formulation.
• Active ocular rosacea (eg, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.

Where it is running

• Foamix Investigational Site # 127 — Fremont, California, United States
• Foamix Investigational Site #155 — Los Angeles, California, United States
• Foamix Investigational Site #143 — Northridge, California, United States
• Foamix Investigational Site # 131 — Oceanside, California, United States
• Foamix Investigational Site #156 — Oceanside, California, United States
• Foamix Investigational Site #153 — San Diego, California, United States
• Foamix Investigational Site # 114 — San Diego, California, United States
• Foamix Investigational Site # 116 — San Luis Obispo, California, United States
• Foamix Investigational Site # 135 — Santa Ana, California, United States
• Foamix Investigational Site # 123 — Santa Monica, California, United States
• Foamix Investigational Site # 109 — Clearwater, Florida, United States
• Foamix Investigational Site # 112 — Hialeah, Florida, United States
• Foamix Investigational Site #150 — Lake Worth, Florida, United States
• Foamix Investigational Site #149 — Miami, Florida, United States
• Foamix Investigational Site #151 — Miami, Florida, United States
• Foamix Investigational Site #144 — Miami Lakes, Florida, United States
• Foamix Investigational Site # 104 — Ormond Beach, Florida, United States
• Foamix Investigational Site # 121 — Sanford, Florida, United States
• Foamix Investigational Site #154 — Sweetwater, Florida, United States
• Foamix Investigational Site # 125 — Tampa, Florida, United States
• Foamix Investigational Site # 142 — West Palm Beach, Florida, United States
• Foamix Investigational Site # 124 — West Palm Beach, Florida, United States
• Foamix Investigational Site # 118 — Alpharetta, Georgia, United States
• Foamix Investigational Site # 139 — Snellville, Georgia, United States
• Foamix Investigational Site #152 — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.