Status:
COMPLETED
A Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 in the Treatment of Moderate to Severe Papulopustular Rosacea
Lead Sponsor:
Vyne Therapeutics Inc.
Conditions:
Papulopustular Rosacea
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
This is an open-label, multicenter, 40-week extension study to evaluate the long-term safety, tolerability, and efficacy of FMX103 1.5% topical foam in the treatment of moderate-to-severe facial papul...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2019
Estimated Enrollment :
504 Patients enrolled
Trial Details
Trial ID
NCT03276936
Start Date
September 5 2017
End Date
January 15 2019
Last Update
January 18 2022
Active Locations (79)
Enter a location and click search to find clinical trials sorted by distance.
1
Foamix Investigational Site # 207
Glendale, Arizona, United States, 85308
2
Foamix Investigational Site # 202
Hot Springs, Arkansas, United States, 71913
3
Foamix Investigational Site # 222
Rogers, Arkansas, United States, 72758
4
Foamix Investigational Site # 127
Fremont, California, United States, 94538