Phase 3 results: topical clascoterone shows good efficacy for facial acne

  • Hebert A & al.
  • JAMA Dermatol
  • 22 Apr 2020

  • curated by Brian Richardson, PhD
  • Clinical Essentials
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Takeaway

  • Topical clascoterone cream 1% is associated with clinical efficacy and good safety in patients with facial acne, according to results from 2 phase 3 randomized clinical trials.

Why this matters

  • Acne is a widespread skin condition that negatively affects QoL, and novel treatments have been lacking.

Study design

  • In CB-03-01/25, 353 patients with acne were randomly assigned to clascoterone cream 1% and 355 were randomly assigned to vehicle cream.
  • In CB-03-01/26, 369 patients were randomly assigned to clascoterone cream 1% and 363 were randomly assigned to vehicle cream.
  • Funding: Cassiopea SpA.

Key results

  • At week 12, rates of treatment success (Investigator’s Global Assessment score 0/1) were significantly higher in patients treated with clascoterone vs vehicle:
    • 18.4% vs 9.0% (P<.001 cb-03-01>
    • 20.3% vs 6.5% (P<.001 cb-03-01>
  • Clascoterone vs vehicle was also associated with greater reductions in:
    • Noninflammatory lesions:
      • −19.4 vs −13.0 (P<.001 cb-03-01>
      • −19.4 vs −10.8 (P<.001 cb-03-01>
    • Inflammatory lesions:
      • −19.3 vs −15.5 (P=.003; CB-03-01/25). 
      • −20.0 vs −12.6 (P<.001 cb-03-01>
  • Clascoterone was well tolerated and demonstrated a similar safety profile as vehicle.
    • The most common treatment-emergent adverse events were nasopharyngitis, headache, and oropharyngeal pain.

Limitations

  • Short trial duration.