Acne: minocycline topical foam does well in phase 3 trial

  • Raoof TJ & al.
  • J Am Acad Dermatol
  • 1 Jun 2019

  • International Clinical Digest
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Takeaway

  • A 4% topical minocycline foam (FMX101) demonstrated efficacy and safety for treatment of moderate to severe acne vulgaris in a phase 3 trial.

Why this matters

  • Topical formulation may help minimize systemic adverse effects associated with oral administration.

Key results

  • FMX101 was associated with a greater reduction in inflammatory lesion number (16.93 vs 13.40; P<.0001 compared with vehicle at weeks. style="list-style-type:circle;">
  • Similar results were found at 6 weeks (13.09 vs 9.57; P<.0001 and weeks vs>
  • FMX101 was associated with a greater rate of Investigator’s Global Assessment treatment success ("clear" or "almost clear" with a ≥2-grade improvement; 30.8% vs 19.6%; risk ratio [RR], 1.58; P<.0001 compared with vehicle at weeks. style="list-style-type:circle;">
  • Similar results were found at 6 weeks (11.59% vs 6.52%; RR, 1.78; P<.0005 and weeks vs rr>
  • Treatment-related adverse events were reported in 3.8% of patients treated with FMX101 and 4.0% of patients treated with vehicle.
  • Study design

    • 1488 patients with moderate to severe acne vulgaris were randomly assigned to receive FMX101 4% (N=738) or foam vehicle (N=750) for 12 weeks.
    • Funding: Foamix Pharmaceuticals, Inc.

    Limitations

    • Patient with mild acne not included.