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Introduction <p>In vitro, clascoterone inhibits androgen-induced sebum production—a key driver of acne pathogenesis—although the exact mechanism of action of clascoterone for the treatment of acne is unknown. This study evaluated reductions in casual sebum production following 12&#xa0;weeks of clascoterone cream 1% treatment in patients with acne.</p> Methods <p>Patients ≥ 12&#xa0;years old with mild-to-moderate acne applied clascoterone cream 1% twice daily for 12&#xa0;weeks. The primary endpoint was the reduction in casual sebum measurements at Week 12. Additional endpoints included Investigator’s Global Assessment (IGA) score, inflammatory and noninflammatory lesion counts (ILC and NILC), and tolerability. Data were analyzed using Student’s <i>t</i>-test and Wilcoxon signed-rank test.</p> Results <p>Forty patients with a mean age of 20.9&#xa0;years were enrolled, all of whom completed Week 12. Significant percentage reductions from baseline were observed in sebum measurements (27%), ILC (54%), and NILC (34%; all <i>p</i> &lt; 0.001), and patients achieved a 29% reduction in IGA score. No tolerability or safety issues were identified during the 12-week interim analysis period.</p> Conclusion <p>Clascoterone cream 1% led to significant reductions in sebum measurements with improvements in acne severity and was well tolerated.</p> Trial Registration <p>ClinicalTrials.gov identifier, NCT06415279.</p>

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Reduction in Facial Sebum Production Following Treatment with Clascoterone Cream 1% in Patients with Acne Vulgaris: 12-Week Interim Analysis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年7月19日

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  • Zoe D. Draelos,
  • Kizito Kyeremateng,
  • Nicholas Squittieri

摘要

Introduction

In vitro, clascoterone inhibits androgen-induced sebum production—a key driver of acne pathogenesis—although the exact mechanism of action of clascoterone for the treatment of acne is unknown. This study evaluated reductions in casual sebum production following 12 weeks of clascoterone cream 1% treatment in patients with acne.

Methods

Patients ≥ 12 years old with mild-to-moderate acne applied clascoterone cream 1% twice daily for 12 weeks. The primary endpoint was the reduction in casual sebum measurements at Week 12. Additional endpoints included Investigator’s Global Assessment (IGA) score, inflammatory and noninflammatory lesion counts (ILC and NILC), and tolerability. Data were analyzed using Student’s t-test and Wilcoxon signed-rank test.

Results

Forty patients with a mean age of 20.9 years were enrolled, all of whom completed Week 12. Significant percentage reductions from baseline were observed in sebum measurements (27%), ILC (54%), and NILC (34%; all p < 0.001), and patients achieved a 29% reduction in IGA score. No tolerability or safety issues were identified during the 12-week interim analysis period.

Conclusion

Clascoterone cream 1% led to significant reductions in sebum measurements with improvements in acne severity and was well tolerated.

Trial Registration

ClinicalTrials.gov identifier, NCT06415279.