Minocycline foam shows good efficacy for rosacea in phase 3 trials

  • Gold LS & al.
  • J Am Acad Dermatol
  • 28 ene. 2020

  • de Brian Richardson, PhD
  • Clinical Essentials
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Takeaway

  • FMX103 1.5%, a minocycline 1.5% foam, is efficacious and shows good safety for patients with moderate to severe papulopustular rosacea, according to results from 2 phase 3 trials (FX2016-11 and FX2016-12).

Why this matters

  • Effective topical treatment options are lacking for patients with rosacea.

Key results

  • FMX103 1.5% was associated with a greater reduction in inflammatory lesion number compared with vehicle control:
    • −17.57 vs −15.65 (P=.0031) in the FX2016-11 trial. 
    • −18.54 vs −14.88 (P<.0001 the fx2016-12 trial.>
  • FMX103 1.5% was associated with higher rates of Investigator Global Assessment treatment success compared with vehicle control:
    • 52.1% vs 43.0% (P=.0273) in FX2016-11.
    • 49.1% vs 39.0% (P=.0077) in FX2016-12.
  • No serious treatment-related treatment-emergent adverse events (TEAEs) were reported.
  • The most common noncutaneous TEAEs were viral upper respiratory tract infection, upper respiratory tract infection, and headache.

Study design

  • FMX2016-11 included 751 patients with rosacea: 495 who received FMX103 1.5%, and 256 who received vehicle foam.
  • FMX2016-12 included 771 patients with rosacea: 514 who received FMX103 1.5%, and 257 who received vehicle foam.
  • Funding: Foamix Pharmaceuticals Inc.

Limitations

  • Selected clinical trial population may not reflect real-world scenarios.