Phase 3
Completed N=495
A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne
Source: ClinicalTrials.gov NCT02815280 ↗Enrolled (actual)
495
Serious AEs
0.8%
Results posted
Nov 2020
Primary outcomePrimary: Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12 — 13.78; 10.64 Lesions — p=0.0051
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12 |
13.78; 10.64 | 0.0051 sig |
| PRIMARY Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 12 |
14.66; 7.89 | 0.0424 sig |
| SECONDARY Percent Change From Baseline in the Non-inflammatory Lesion Count at Week 12 |
26.33; 13.49 | 0.0155 sig |
| SECONDARY Absolute Change From Baseline in the Inflammatory Lesion Count at Week 6 and Week 9 |
12.90; 9.01; 13.42; 9.64 | 0.0001 sig |
| SECONDARY Percentage of Participants Achieving IGA Treatment Success at Week 6 and Week 9 |
4.68; 0.81; 7.61; 5.97 | 0.0071 sig |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |
110; 45; 120; 9; 3; 8 | — |
Eligibility Criteria
Inclusion Criteria
- Has facial acne vulgaris with:
- 20 to 50 inflammatory lesions (papules, pustules, and nodules)
- 25 to 100 noninflammatory 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 (NCT02815280). 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. Informational only — not medical advice.