Original article
Efficacy and safety of a novel topical minocycline foam for the treatment of moderate to severe acne vulgaris: A phase 3 study

https://doi.org/10.1016/j.jaad.2019.05.078Get rights and content
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Background

FMX101 4% topical minocycline foam has been shown to be an effective and safe treatment for acne vulgaris (AV).

Objective

To further evaluate the efficacy and safety of FMX101 4% in treating moderate to severe acne vulgaris.

Methods

A 12-week, multicenter, randomized (1:1), double-blind, vehicle-controlled study was conducted. Coprimary end points were the absolute change in inflammatory lesion count from baseline and the rate of treatment success (Investigator's Global Assessment score of 0 or 1 with a ≥2-grade improvement).

Results

There were 1488 participants in the intent-to-treat population. The FMX101 4% group had significantly greater reductions in the number of inflammatory lesions from baseline (P < .0001) and a greater rate of treatment success based on Investigator's Global Assessment (P < .0001) versus the foam vehicle group at week 12. FMX101 4% was generally safe and well tolerated.

Limitations

The efficacy and safety of FMX101 4% were not characterized in participants with mild AV.

Conclusion

FMX101 4% topical minocycline foam was effective and safe for the treatment of moderate to severe AV.

Key words

acne vulgaris
clinical study
efficacy
foam
minocycline
randomized
safety
topical administration

Abbreviations used

AV
acne vulgaris
CI
confidence interval
CK
creatine phosphokinase
IGA
Investigator's Global Assessment
LSM
least squares mean
TEAE
treatment-emergent adverse event
AE
adverse event
ITT
intent to treat

Cited by (0)

Funding sources: Sponsored by Foamix Pharmaceuticals, Inc.

Disclosure: Drs Raoof, Hooper, Zaiac, Sullivan, Lain, and Moore served as investigators for Foamix Pharmaceuticals. Dr Kircik is an investigator and consultant for Foamix Pharmaceuticals. Dr Jankicevic is a consultant for Foamix Pharmaceuticals. Dr Stuart is an employee and stockholder at Foamix Pharmaceuticals.