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