Phase 3
N=1,488
A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT03271021 ↗Enrolled (actual)
1,488
Serious AEs
0.3%
Results posted
Feb 2020
Primary outcome: Primary: The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12. — 16.39; 12.74 Lesion Count
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- FMX101 (Drug); Vehicle Foam (Drug)
- Age
- Pediatric, Adult, Older Adult · 9+ yrs
- Sex
- All
- Sponsor
- Vyne Therapeutics Inc.
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12. |
16.39; 12.74 | — |
| PRIMARY Investigator Global Assessment (IGA) Treatment Success (Dichotomized as Yes/no) at Week 12, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline |
199; 133 | — |
| SECONDARY The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12 |
18.80; 15.89 | — |
| SECONDARY The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9 |
15.59; 11.72 | — |
| SECONDARY The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6 |
13.09; 9.57 | — |
| SECONDARY IGA Treatment Success (Dichotomized as Yes/no) at Week 6, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 6 |
84; 46 | — |
| SECONDARY IGA Treatment Success (Dichotomized as Yes/no) at Week 9, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 9 |
137; 79 | — |
Summary
A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris (Study FX2017-22)
Eligibility Criteria
Inclusion Criteria
- Has facial acne vulgaris with:
- 20 to 50 inflammatory lesions (papules, pustules, and nodules)
- 25 to 100 non-inflammatory lesions (open and closed comedones)
- No more than 2 nodules on the face
- IGA score of moderate (3) to severe (4)
- Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin Cleanser) and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study.
Exclusion Criteria
- Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations.
- Sunburn on the face.
Data sourced from ClinicalTrials.gov (NCT03271021). 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.