Clascoterone cream exhibits significant long-term improvement among children with acne

Key takeaways:

• The proportion of patients with facial acne that reached IGA 0/1 increased from 13.5% to 48.9% after 9 months of treatment.
• IGA 0/1 success among patients with truncal acne increased from 4% to 52.4%.

Clascoterone cream 1% may be a safe and effective alternative to traditional medications for the long-term treatment of acne vulgaris in patients aged 12 years and older, according to a phase 3 extension trial.

“Clascoterone safety was well maintained for up to an additional 9 months of treatment in patients [aged 9 years and older] with moderate to severe acne vulgaris,” 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 UC San Diego School of Medicine, and colleagues wrote. “Here, we present long-term safety and efficacy data in the subgroup of clinical trial patients [aged 12 years and older] who entered the long-term extension study.”

The study, which was an extension trial from two phase 3 studies, ultimately included 343 patients who applied clascoterone cream 1% (n = 177) or vehicle (n = 166) twice daily to the entire face or trunk for up to 9 months.

Results showed that the proportion of patients with facial acne that reached IGA 0/1 increased from 13.5% at baseline to 48.9% after 9 months of treatment.

Patients who entered the extension trial with a facial IGA of 0/1 included 18% of those treated with clascoterone in the original study and 8.6% of those treated with vehicle. Both cohorts experienced increased IGA success over time (50.3% vs. 47.4%, respectively).

Similarly, the proportion of patients with truncal acne that reached IGA 0/1 increased from 4% at baseline to 52.4% at the end of the study. Although IGA success was not contingent on whether patients with truncal acne had previous exposure to facial clascoterone treatment, those who were originally randomly assigned to clascoterone showed the highest rate of IGA 0/1 achievement (61.2%).

Results in the extension trial were similar to those in the original study population which included children aged as young as 9 years with a facial IGA 0/1 success of 48.1% and truncal IGA 0/1 success of 52.3%.

The extension trial also confirmed the favorable safety profile of clascoterone cream 1% with treatment-emergent adverse events occurring in 18.1% of patients. The most common events in both the clascoterone and vehicle cohorts were erythema (face, 8% vs. 7.7%, respectively) and scaling/dryness (face, 10% vs. 7.3%).

“Clascoterone cream 1% exhibited favorable long-term safety and efficacy during treatment up to 12 months in patients [aged 12 years and older] with moderate to severe acne vulgaris and may be a safe and effective alternative to traditional acne medications for long-term treatment,” the authors concluded.