Clascoterone cream shows good long-term safety in patients with acne

  • Eichenfield L & al.
  • J Am Acad Dermatol
  • 26 abr. 2020

  • de Brian Richardson, PhD
  • Clinical Essentials
El acceso al contenido completo es sólo para profesionales sanitarios registrados. El acceso al contenido completo es sólo para profesionales sanitarios registrados.

Takeaway

  • Clascoterone cream 1% is associated with a rate of treatment-emergent adverse events (TEAEs) similar to rates with vehicle, according to a long-term, open-label extension of phase 3 trials.

Why this matters

  • Phase 3 trials often have a short duration, necessitating long-term follow-up to properly assess safety.

Key results

  • 110 patients (18.1%) experienced 191 TEAEs.
  • The proportion of patients who received clascoterone and experienced TEAEs was similar to the proportion among those who received vehicle (18.3% vs 17.9%).
  • 1.5% of patients experienced a TEAE that led to discontinuation: 
    • 2.8% of the clascoterone group and 0% of the vehicle group.
  • 1.0% of patients experienced a serious TEAE:
    • 0.9% of the clascoterone group and 1.0% of the vehicle group.
  • The most frequently reported TEAE was nasopharyngitis.
  • The most frequent local skin reactions were erythema, scaling/dryness, and pruritus.

Study design

  • 607 patients (n=317, clascoterone BID; n=290, vehicle) were included.
  • 347 patients completed the study: 179 in the clascoterone group and 168 in the vehicle group.
  • Funding: Cassiopea SpA, Italy.

Limitations

  • Long-term efficacy was not a primary endpoint.
  • Many patients withdrew or were lost to follow-up.