Long-term safety, efficacy of clascoterone cream shown in acne treatment
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MIAMI BEACH, Fla. — Clascoterone cream 1% demonstrated long-term efficacy and a favorable safety profile in patients aged older than 12 years with acne vulgaris, according to extension study results presented here.
“Clascoterone cream 1% is a topical androgen receptor inhibitor approved for the treatment of acne vulgaris in patients aged [at least] 12 years old,” Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital and professor of dermatology and pediatrics and vice chair of the department of dermatology at University of California, San Diego, and colleagues wrote in a poster presented at South Beach Symposium.
Clascoterone cream 1% demonstrated long-term efficacy and a favorable safety profile in patients aged older than 12 years with acne vulgaris.
The multicenter, open-label, long-term extension study included patients who completed one of the 12-week phase 3 clinical trials. Patients used clascoterone cream 1% to the face and to truncal acne twice daily for an additional 9 months.
In the subgroup of patients aged 12 and older, treatment-emergent adverse events occurred in 18.1% of patients, with most being mild and not considered related to the treatment.
Nasopharyngitis and upper respiratory tract infection were the most commonly reported treatment-emergent adverse events.
Of those treated with clascoterone cream for both the initial trial and the extension trial, 50.3% had clear or almost clear facial acne at the end of 12 months. For those who were treated with vehicle in the initial trial and switched to clascoterone cream in the extension trial, 47.4% had clear or almost clear skin.
For those who used the treatment for truncal acne, 61.2% of the clascoterone-to-clascoterone group had an IGA of 0/1 at the end of the trial, where 42.1% of the vehicle-to-clascoterone group experienced 0/1 IGA score.
“Among patients who completed the study without major protocol violation, the proportion achieving clear or almost clear skin of the face and trunk increased with duration of 1% clascoterone cream treatment and was highest for patients on-study for 12 months of treatment,” the authors wrote.