Phase 3
N=751
A Study (Study 1) 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: NCT03142451 ↗Enrolled (actual)
751
Serious AEs
0.7%
Results posted
Dec 2020
Primary outcome: Primary: The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Count at Week 12 — 17.56; 15.34 Lesions — p=0.0031
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
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Count at Week 12 |
17.56; 15.34 | 0.0031 sig |
| PRIMARY Percentage of Participants Achieving Investigator Global Assessments (IGA) Treatment Success at Week 12 |
52.1; 43.0 | 0.0273 sig |
| SECONDARY Percentage of Participants Achieving IGA Treatment Success of at Least 2 Grades at Week 12 |
55.3; 45.8 | 0.0171 sig |
| SECONDARY The Percent Change From Day 0/Baseline in Inflammatory Lesion Count at Week 12 |
64.13; 56.52 | 0.0039 sig |
| SECONDARY The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Counts at Week 4 and Week 8 |
11.24; 8.62; 15.59; 12.51 | 0.0004 sig |
| SECONDARY Percentage of Participants Achieving IGA Treatment Success at Week 4 and Week 8 |
15.3; 9.1; 35.2; 29.4 | 0.0201 sig |
| SECONDARY Number of Participants With Adverse Events (AEs) |
98; 58; 91; 54; 2; 3 | — |
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 (NCT03142451). 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.