Data showcase efficacy of Winlevi as acne treatment

Key takeaways:

• Winlevi reduced the appearance of an oily face by 8% (P = .008) at week 4 and 40% (P < .001) by week 12.
• When layered with other topical acne medications, 98% to 119% of Winlevi was still present after 8 hours.

New data showed Winlevi reduced oil production, remained stable when used in conjunction with other topical acne medications and improved outcomes in skin of color, Sun Pharma announced in a press release.

Presented at the Fall Clinical Dermatology Conference, three separate studies showcased the ability of Winlevi (clascoterone) cream 1% to effectively treat acne.

“This is exciting news for people living with acne because this is the first study to demonstrate a reduction in measured facial sebum production following the use of clascoterone cream 1%,” Zoe D. Draelos, MD, of Dermatology Consulting Services PLLC and lead investigator of the trial, said in the release.

The first set of data consisted of 12-week interim results from a yearlong study evaluating the ability of Winlevi to reduce facial sebum production in patients with acne. Forty patients (mean age, 20.9 years; 60% female; 63% white) were included in the study.

Patients had mild (57.5%) or moderate acne (42.5%). The mean sebum rate as measured by Sebumeter (Courage + Khazaka) was 115.9 ± 50.5 at the start of the study.

After 6 weeks of Winlevi treatment, sebum production was reduced by 22% (P = .002). Sebum production only reduced by 19% (P = .005) at week 10 but then increased to 27% (P < .001) by week 12.

The appearance of an oily face also reduced by 8% (P = .008) at week 4 and 40% (P < .001) by week 12. Pore size and facial shine levels also decreased by 23% and 39% at week 12 (P < .001 for both).

Also at 12 weeks, IGA score saw a reduction of 29%, and the numbers of inflammatory and noninflammatory lesions reduced by 54% and 34% (P < .001 for all). All of this was achieved with high tolerability.

Another study found that Winlevi’s efficacy remained stable when layered with other topical acne medications. Results showed that 98% to 119% of Winlevi remained after testing, which indicated no degradation of the drug.

The third study evaluated the efficacy of Winlevi in patients with skin of color with acne. Sixteen-week interim results were presented from the 56-week, single-center, open-label pilot study consisting of 10 patients (mean age, 24 years) with Fitzpatrick skin types IV, V and VI.

By the end of the interim period, 78% of patients achieved an IGA score of 0 or 1 (P = .008). Patients also achieved significant reductions in inflammatory (91.8%; P = .008), noninflammatory (90.9%; P = .009) and total lesions (90.9%; P = .009). So far, there have been no reports of adverse events.

Editor's note: On Oct. 3, the article was corrected to reflect that the represented data were part of three studies. The editors regret the error.