Phase 3
Completed N=466
A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne
Source: ClinicalTrials.gov NCT02815267 ↗Enrolled (actual)
466
Serious AEs
0.3%
Results posted
Sep 2020
Primary outcomePrimary: Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12 — 13.95; 11.15 Lesion counts — p=0.0083
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 |
13.95; 11.15 | 0.0083 sig |
| PRIMARY Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 12 |
8.09; 4.77 | 0.1805 |
| SECONDARY Percent Change From Baseline in the Non-inflammatory Lesion Count at Week 12 |
32.34; 19.60 | 0.0040 sig |
| SECONDARY Absolute Change From Baseline in the Inflammatory Lesion Count at Week 6 and Week 9 |
11.65; 7.79; 13.24; 8.85 | 0.0002 sig |
| SECONDARY Percentage of Participants Achieving IGA Treatment Success at Week 6 and Week 9 |
3.47; 0.75; 4.19; 1.43 | 0.0395 sig |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and and Treatment-emergent Serious Adverse Events (TESAEs) |
52; 29; 65; 6; 4; 5 | — |
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; and
- 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
- Severe systemic disease, which might interfere with the conduct of the study or the interpretation of the results.
- Abnormal baseline laboratory values that are considered clinically significant
- Allergy to tetracycline-class antibiotics or to any ingredient in the study drug
- Pseudomembranous colitis or antibiotic-associated colitis
Data sourced from ClinicalTrials.gov (NCT02815267). 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.