- 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.
- 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.
- 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>
- Noninflammatory lesions:
- −19.4 vs −13.0 (P<.001 cb-03-01>
- −19.4 vs −10.8 (P<.001 cb-03-01>
- −19.3 vs −15.5 (P=.003; CB-03-01/25).
- −20.0 vs −12.6 (P<.001 cb-03-01>
- The most common treatment-emergent adverse events were nasopharyngitis, headache, and oropharyngeal pain.
- Short trial duration.