一项开放性研究，旨在评估 7.5%氨苯砜凝胶治疗有色人种男性和女性寻常痤疮的疗效和耐受性。

An Open-label Study to Investigate the Efficacy and Tolerability of Dapsone Gel, 7.5% in the Treatment of Acne Vulgaris in Men and Women With Skin of Color.

出版信息

J Drugs Dermatol. 2024 Jun 1;23(6):410-417. doi: 10.36849/JDD.7897.

Abstract

INTRODUCTION

Acne vulgaris is a common skin disease prevalent in skin of color patients. Studies have demonstrated that dapsone gel, 7.5% (Aczone) used once daily is effective, safe, and well-tolerated for the treatment of acne in both men and women. However, minimal data are available in skin of color populations. This single-center, open-label clinical study investigated the efficacy and safety of dapsone gel, 7.5% in the treatment of moderate to severe acne vulgaris in patients with Fitzpatrick skin types IV-VI.

METHODS

Twenty (20) adult subjects with moderate to severe acne and Fitzpatrick skin types IV-VI were enrolled in this study and treated with dapsone gel, 7.5% once daily for 24 weeks.

RESULTS

Dapsone gel, 7.5% applied daily for 24 weeks reduced acne severity, post-inflammatory hyperpigmentation, and decreased new inflammatory and noninflammatory acne lesions in skin of color patients with moderate to severe acne vulgaris. Treatment resulted in improved acne health-related quality of life and patient symptoms related to acne, including patient-reported post-inflammatory hyperpigmentation, especially with a treatment duration of 18 weeks or longer. Limitations: The sample size was small and underpowered to detect statistically significant changes in some endpoints.

CONCLUSION

Dapsone gel 7.5% was safe, well-tolerated, and efficacious in treating acne vulgaris and post-inflammatory hyperpigmentation in skin-of-color patients. Larger studies involving skin-of-color populations with acne vulgaris are warranted. J Drugs Dermatol. 2024;23(6):410-417. doi:10.36849/JDD.7897.

摘要

简介

寻常痤疮是一种常见的皮肤病，在有色人种患者的皮肤中更为普遍。研究表明，每日一次使用 7.5%达泊西汀凝胶对于男性和女性的痤疮治疗是有效、安全且耐受良好的。然而，在有色人种人群中，数据很少。这项单中心、开放性临床研究调查了 7.5%达泊西汀凝胶在治疗 Fitzpatrick 皮肤类型 IV-VI 的中重度寻常痤疮患者中的疗效和安全性。

方法

本研究纳入了 20 名患有中重度痤疮且 Fitzpatrick 皮肤类型为 IV-VI 的成年患者，他们接受了每日一次的 7.5%达泊西汀凝胶治疗，为期 24 周。

结果

7.5%达泊西汀凝胶每日应用 24 周可降低中重度寻常痤疮有色人种患者的痤疮严重程度、炎症后色素沉着，并减少新的炎症性和非炎症性痤疮病变。治疗可改善与痤疮相关的皮肤健康相关生活质量和患者症状，包括患者报告的炎症后色素沉着，特别是治疗持续 18 周或更长时间时。局限性：样本量较小，不足以检测到某些终点的统计学显著变化。