A Study (Study 2) 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

NCT04608500

Run by

Vyne Therapeutics Inc.

People needed

771

Starts

2017-06-01

Expected to finish

2018-07-31

Last updated by the study team

2021-01-07

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 # 207 — Glendale, Arizona, United States
• Foamix Investigational Site # 202 — Hot Springs, Arkansas, United States
• Foamix Investigational Site # 222 — Rogers, Arkansas, United States
• Foamix Investigational Site #244 — Encino, California, United States
• Foamix Investigational Site #249 — Huntington Beach, California, United States
• Foamix Investigational Site # 226 — Los Angeles, California, United States
• Foamix Investigational Site # 220 — Murrieta, California, United States
• Foamix Investigational Site #251 — North Hollywood, California, United States
• Foamix Investigational Site # 217 — San Diego, California, United States
• Foamix Investigational Site #250 — San Marcos, California, United States
• Foamix Investigational Site # 239 — Temecula, California, United States
• Foamix Investigational Site # 227 — Denver, Colorado, United States
• Foamix Investigational Site # 223 — Boca Raton, Florida, United States
• Foamix Investigational Site # 215 — Boynton Beach, Florida, United States
• Foamix Investigational Site #245 — DeLand, Florida, United States
• Foamix Investigational Site # 240 — Fort Myers, Florida, United States
• Foamix Investigational Site #247 — Hialeah, Florida, United States
• Foamix Investigational Site #252 — Hialeah, Florida, United States
• Foamix Investigational Site # 214 — Miami, Florida, United States
• Foamix Investigational Site #246 — Miami, Florida, United States
• Foamix Investigational Site # 241 — North Miami Beach, Florida, United States
• Foamix Investigational Site #248 — Oldsmar, Florida, United States
• Foamix Investigational Site # 204 — Newnan, Georgia, United States
• Foamix Investigational Site # 211 — Arlington Heights, Illinois, United States
• Foamix Investigational Site # 225 — Newburgh, Indiana, United States

Full record on ClinicalTrials.gov

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