A Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 in the Treatment of Moderate to Severe Papulopustular Rosacea

Completed · Phase 3

Conditions studied: Papulopustular Rosacea

In brief

The primary objective is to show that open-label extended treatment with FMX103 1.5%, for up to an additional 40 weeks, is safe and well tolerated.

Key facts

Study ID

NCT03276936

Run by

Vyne Therapeutics Inc.

People needed

504

Starts

2017-09-05

Expected to finish

2019-01-15

Last updated by the study team

2022-01-18

Who can join

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

You may qualify if…

• Have completed 12 weeks of treatment in either Study FX2016-11 or Study FX2016-12.
• Have not had a worsening of disease, determined by the Investigator's Global Assessment (IGA), at Visit 5/Week 12 (Final Visit) relative to the Day 0/Baseline assessment in Study FX2016-11 or Study FX2016-12.

You may not qualify if…

• Have a new systemic disease or condition, including an ongoing AE that might interfere with the conduct of the study or the interpretation of results.
• Have developed a condition that would have been exclusionary for Study FX2016-11 or Study FX2016-12, including pseudomembranous colitis, antibiotic associated colitis, hepatitis, liver damage, renal impairment, drug addiction, or alcohol abuse.

Where it is running

• Foamix Investigational Site # 202 — Hot Springs, Arkansas, United States
• Foamix Investigational Site # 222 — Rogers, Arkansas, United States
• Foamix Investigational Site # 127 — Fremont, California, United States
• Foamix Investigational Site # 226 — Los Angeles, California, United States
• Foamix Investigational Site # 220 — Murrieta, California, United States
• Foamix Investigational Site # 131 — Oceanside, California, United States
• Foamix Investigational Site # 134 — Sacramento, 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 # 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 # 109 — Clearwater, Florida, United States
• Foamix Investigational Site # 240 — Fort Myers, Florida, United States
• Foamix Investigational Site # 112 — Hialeah, Florida, United States
• Foamix Investigational Site # 214 — Miami, Florida, United States
• Foamix Investigational Site # 241 — North Miami Beach, Florida, United States
• Foamix Investigational Site # 104 — Ormond Beach, Florida, United States
• Foamix Investigational Site # 121 — Sanford, Florida, United States
• Foamix Investigational Site # 125 — Tampa, Florida, United States
• Foamix Investigational Site # 124 — West Palm Beach, Florida, United States
• Foamix Investigational Site # 207 — Glendale, 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.