每日两次外用 1%氯柳酊治疗 12 岁及以上寻常痤疮患者的长期安全性和疗效。

Long-Term Safety and Efficacy of Twice-Daily Topical Clascoterone Cream 1% in Patients Greater Than or Equal to 12 Years of Age With Acne Vulgaris.

出版信息

J Drugs Dermatol. 2023 Aug 1;22(8):810-816. doi: 10.36849/jdd.7592.

Abstract

BACKGROUND

Clascoterone cream 1% is approved for the treatment of acne vulgaris in patients aged ≥ 12 years based on results from two 12-week Phase 3 studies in patients with moderate-to-severe acne. Safety and efficacy of clascoterone in patients aged ≥ 12 years from an open-label, long-term extension study are presented. Methods: Enrolled patients applied clascoterone cream 1% twice daily to the entire face and, if desired by the patient and/or investigator, truncal acne, for up to 9 months. Patients achieving Investigator’s Global Assessment score of 0 or 1 (IGA 0/1) could stop treatment and resume if/when acne worsened. Safety was assessed from treatment-emergent adverse events (TEAEs) and local skin reactions (LSRs [telangiectasia, skin atrophy, striae rubrae, erythema, edema, scaling/dryness, stinging/burning, and pruritus]) in all treated patients. Efficacy was assessed from IGA at each visit among those completing the study per-protocol (PP); face and trunk were evaluated individually. Results: Of 600 patients aged ≥ 12 years (original randomization: 311 clascoterone, 289 vehicle), 343 completed the extension study (177 clascoterone, 166 vehicle). There were 187 TEAEs in 108/598 clascoterone-treated patients (18.1%), including 56/311 (18.0%) and 52/287 (18.1%) patients originally randomized to clascoterone and vehicle, respectively; the most common LSRs (previous clascoterone/vehicle) were erythema (face, 8.0%/7.7%) and scaling/dryness (face, 10.0%/7.3%). The percentage of PP patients with facial and truncal IGA 0/1 increased to 48.9% (156/319) and 52.4% (65/124), respectively, at study end.

CONCLUSIONS

Clascoterone cream 1% maintained a favorable safety and efficacy profile for up to 12 months in patients aged ≥ 12 years. Eichenfield LF, Hebert AA, Stein Gold L, et al. Long-term safety and efficacy of twice-daily topical clascoterone cream 1% in patients ≥ 12 years of age with acne vulgaris. J Drugs Dermatol. 2023;22(8):810-816. doi:10.36849/JDD.7592.

摘要

背景

基于两项为期 12 周的中重度痤疮患者的 3 期研究结果，1%氯司替勃乳膏获准用于治疗年龄≥12 岁的寻常痤疮患者。本文报告了一项开放标签、长期扩展研究中年龄≥12 岁的患者使用氯司替勃乳膏的安全性和疗效。方法：纳入的患者每天两次将氯司替勃乳膏 1%涂抹于整个面部，如果患者和/或研究者希望治疗躯干部痤疮，也可使用。患者若达到研究者整体评估（IGA）评分 0 或 1（IGA 0/1），可停止治疗，在痤疮恶化时恢复治疗。所有治疗患者均评估治疗期间出现的不良事件（TEAEs）和局部皮肤反应（LSRs[毛细血管扩张、皮肤萎缩、红纹、红斑、水肿、脱屑/干燥、刺痛/灼热、瘙痒]）以评估安全性。根据符合方案人群（PP）中每位患者的 IGA 在每次就诊时评估疗效；面部和躯干部分别评估。结果：在 600 名年龄≥12 岁的患者（原随机分组：氯司替勃 311 例，赋形剂 289 例）中，343 例完成了扩展研究（氯司替勃 177 例，赋形剂 166 例）。在 598 例接受氯司替勃治疗的患者中，有 187 例发生 TEAEs（108 例，18.1%），包括 56 例（18.0%）和 52 例（18.1%）分别随机接受氯司替勃和赋形剂治疗的患者；最常见的 LSRs（既往氯司替勃/赋形剂）为红斑（面部，8.0%/7.7%）和脱屑/干燥（面部，10.0%/7.3%）。在研究结束时，PP 患者的面部和躯干部 IGA 0/1 的比例分别增加至 48.9%（156/319）和 52.4%（65/124）。结论：氯司替勃乳膏 1%在年龄≥12 岁的痤疮患者中最长可维持 12 个月的良好安全性和疗效。