1%克林霉素凝胶治疗 12 岁及以上寻常痤疮患者的短期和长期疗效观察。

Integrated Short-Term and Long-Term Efficacy of Topical Clascoterone Cream 1% in Patients Aged 12 Years or Older With Acne Vulgaris.

出版信息

J Drugs Dermatol. 2024 Jan 1;23(1):1278-1283. doi: 10.36849/JDD.7719.

PMID:38206145

Abstract

BACKGROUND

Clascoterone cream 1% is approved for the treatment of acne vulgaris in patients aged 12 years or older based on results from two identical pivotal Phase 3 trials. Integrated efficacy of clascoterone in patients aged 12 years or older with acne vulgaris from the pivotal trials (NCT02608450 and NCT02608476) and long-term extension (LTE) study (NCT02682264) is reported.

METHODS

In the pivotal trials, patients with moderate-to-severe acne vulgaris were randomized 1:1 to twice-daily application of clascoterone cream 1% or vehicle for 12 weeks; they could then enter the LTE study, where all patients applied clascoterone to the face and, if desired, trunk for up to 9 additional months. Efficacy was assessed from treatment success based on Investigator's Global Assessment scores (IGA 0/1) in patients aged 12 years or older in the intention-to-treat population; lesion counts were assessed through week 12. Missing data were handled using multiple imputation in the pivotal studies and were not imputed in the LTE study.

RESULTS

Of 1421 patients enrolled, 1143 (clascoterone, 576; vehicle, 567) completed week 12; 600 entered and 343 completed the LTE study. The treatment success rate and most lesion count reductions following clascoterone vs placebo treatment reached statistical significance at week 12; the overall treatment success rate increased to 30.2% for facial acne after 12 months and 31.7% for truncal acne after 9 months of treatment.

CONCLUSIONS

The efficacy of clascoterone cream 1% for the treatment of acne vulgaris continued to increase over time for up to 12 months in patients aged 12 years or older with acne vulgaris. J Drugs Dermatol. 2024;23(1):1278-1283. doi:10.36849/JDD.7719.

摘要

背景

基于两项关键性 3 期临床试验的结果，1%氯螺内酯乳膏获批用于治疗 12 岁及以上年龄患者的寻常痤疮。本文报告了关键性试验（NCT02608450 和 NCT02608476）和长期扩展（LTE）研究（NCT02682264）中，12 岁及以上年龄患有寻常痤疮的患者使用氯螺内酯的综合疗效。

方法

在关键性试验中，中重度寻常痤疮患者按 1:1 比例随机分配，接受氯螺内酯乳膏 1%或赋形剂每日两次治疗 12 周；然后他们可以进入 LTE 研究，所有患者将氯螺内酯应用于面部，如果需要，还可应用于躯干，最长 9 个月。在 12 岁及以上年龄的意向治疗人群中，根据研究者整体评估（IGA 0/1）评分评估治疗成功；通过第 12 周的皮损计数评估疗效。关键性研究中采用多重插补处理缺失数据，LTE 研究中不进行插补。

结果

在纳入的 1421 例患者中，1143 例（氯螺内酯 576 例，赋形剂 567 例）完成了第 12 周；600 例患者进入 LTE 研究，其中 343 例完成了研究。与安慰剂治疗相比，第 12 周时，氯螺内酯治疗的治疗成功率和大多数皮损计数减少均达到统计学意义；面部痤疮治疗 12 个月后总治疗成功率增加至 30.2%，躯干痤疮治疗 9 个月后总治疗成功率增加至 31.7%。