Studies Confirm WINLEVI® Cream 1% Lowers Sebum and Works With Other Acne Treatments

WINLEVI poster presentations at the 2024 Fall Clinical Dermatology Conference also include data affirming reduced acne severity and tolerability in patients with skin of color.

MUMBAI, India and PRINCETON, N.J., Oct. 25, 2024 -- Sun Pharmaceutical Industries Limited, commonly known as Sun Pharma, presented compelling new data supporting the efficacy of WINLEVI® (clascoterone) cream 1% for treating acne. This information was shared through poster presentations at the 44th Annual Fall Clinical Dermatology Conference, emphasizing WINLEVI's ability to significantly reduce sebum production and its compatibility with other common acne treatments. Notably, the data highlighted that WINLEVI effectively reduces acne severity in patients with skin of color, who are often underrepresented in acne studies.

"Seeing new data affirming WINLEVI's role in reducing sebum production and its compatibility with other topical agents is gratifying," said Abhay Gandhi, CEO of North America at Sun Pharma. "It's particularly encouraging to note the reduction in acne severity and tolerability in people of color, who often experience a more significant impact from acne. These findings solidify WINLEVI's position as a reliable and effective acne treatment that dermatologists can prescribe with confidence."

WINLEVI distinguishes itself as the first FDA-approved topical treatment targeting androgen receptors to treat acne in individuals aged 12 and older. Acne vulgaris, a prevalent skin condition affecting up to 50 million Americans, is commonly treated using various topical medications. WINLEVI's efficacy in targeting sebum production, a crucial factor in acne development, sets it apart in the treatment landscape.

A yearlong study presented interim results over 12 weeks, focusing on WINLEVI's impact on facial sebum production. The primary goal was to measure reductions in sebum levels using a sebumeter, which assesses the lipids on the skin's surface. The study also evaluated the reduction in inflammatory and non-inflammatory acne lesions and the improvement of facial shine, pore size, and oily appearance. The 40 participants, primarily female and White, entered the study with mild to moderate acne and an average sebumeter reading of 115.9 ± 50.5.

Significant reductions in sebum levels were observed at six, ten, and twelve weeks, with continued improvements noted in facial shine and pore size. By the twelfth week, patients experienced a 29% reduction in the Investigator's Global Assessment (IGA) score, indicating a significant decrease in acne severity. Both inflammatory and non-inflammatory lesions showed marked reductions, and WINLEVI was well tolerated by the participants, with no adverse reactions reported.

"This is groundbreaking for those affected by acne, as our study is the first to document a reduction in facial sebum following the use of clascoterone cream 1%," commented lead investigator Dr. Zoe D. Draelos. "Our results not only confirm WINLEVI's sebum-reducing effects but also align with previous clinical trials showing fewer acne lesions, further validating the clinical utility of this topical medication."

Additionally, Dr. Draelos and her team studied WINLEVI's stability when combined with other topical acne treatments, such as tretinoin cream and benzoyl peroxide formulations. The medications were incubated with WINLEVI, and subsequent analyses confirmed that WINLEVI's concentrations remained stable, suggesting it does not degrade when used alongside other treatments. This positions WINLEVI as a robust option for combination therapy in acne treatment.

A separate study focused on patients with skin of color reported positive interim results over 16 weeks. The study involved 10 patients with moderate-to-severe acne, and the findings were promising. By the sixteenth week, 78% of participants achieved a near-clear IGA score, with significant reductions in both inflammatory and non-inflammatory lesions. The treatment was well tolerated, with no adverse events reported, underscoring WINLEVI's safety and efficacy in this demographic.

WINLEVI's unique mechanism as an androgen receptor inhibitor makes it a pioneering treatment for acne, offering hope and clarity to many suffering from this widespread skin condition. Sun Pharma's commitment to advancing dermatological treatments continues to be evident through their rigorous research and the development of innovative products like WINLEVI.