Phase 3
N=504
A Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 in the Treatment of Moderate to Severe Papulopustular Rosacea
Papulopustular Rosacea
Bottom Line
View on ClinicalTrials.gov: NCT03276936 ↗Enrolled (actual)
504
Serious AEs
2.6%
Results posted
Dec 2020
Primary outcome: Primary: Absolute Change From Baseline in Inflammatory Lesion Count at Week 40 — 23.0; 22.5 Lesions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- FMX103 1.5% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vyne Therapeutics Inc.
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in Inflammatory Lesion Count at Week 40 |
23.0; 22.5 | — |
| PRIMARY Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 40 |
81.6; 76.0 | — |
| SECONDARY Absolute Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 |
19.5; 17.4; 20.4; 19.8; 21.9; 20.0 | — |
| SECONDARY Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34 |
50.6; 48.2; 60.1; 54.5; 68.1; 64.0 | — |
| SECONDARY Percentage Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 |
67.91; 61.25; 72.43; 69.02; 77.36; 71.46 | — |
| SECONDARY Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 |
178; 82; 0; 2; 110; 47 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
151; 70; 137; 64; 9; 4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03276936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.