Phase 3
N=771
A Study (Study 2) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea
Facial Papulopustular Rosacea
Bottom Line
View on ClinicalTrials.gov: NCT04608500 ↗Enrolled (actual)
771
Serious AEs
0.4%
Results posted
Dec 2020
Primary outcome: Primary: The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Count at Week 12 — 18.38; 14.53 Lesions — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- FMX103 minocycline foam 1.5% (Drug); Vehicle foam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vyne Therapeutics Inc.
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Count at Week 12 |
18.38; 14.53 | <0.0001 sig |
| PRIMARY Percentage of Participants Achieving Investigator Global Assessments (IGA) Treatment Success at Week 12 |
49.1; 39.0 | 0.0077 sig |
| SECONDARY Percentage of Participants Achieving IGA Treatment Success of at Least 2 Grades at Week 12 |
53.8; 45.1 | 0.0189 sig |
| SECONDARY The Percent Change From Day 0/Baseline in Inflammatory Lesion Count at Week 12 |
61.45; 50.16 | <0.0001 sig |
| SECONDARY The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Counts at Week 4 and Week 8 |
12.67; 8.29; 17.15; 12.08 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving IGA Treatment Success at Week 4 and Week 8 |
16.7; 9.7; 40.3; 30.7 | 0.0114 sig |
| SECONDARY Number of Participants With Adverse Events (AEs) |
134; 71; 124; 67; 1; 2 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04608500). 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.