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含0.1%阿达帕林和1%克林霉素的固定剂量复方凝胶治疗寻常痤疮的疗效和安全性（仙人掌研究）：一项随机、对照、评估者盲法的III期临床试验

Efficacy and Safety of a Fixed-Dose Combination Gel with Adapalene 0.1% and Clindamycin 1% for the Treatment of Acne Vulgaris (CACTUS): A Randomized, Controlled, Assessor-Blind, Phase III Clinical Trial.

作者信息

Luan Chao, Yang Wen Lin, Yin Jia Wen, Deng Lie Hua, Chen Bin, Liu Hong Wei, Zhang Shou Min, Han Jian De, Liu Zhi Jun, Dai Xiang Rong, Yin Qiu Ju, Yu Xiao Hui, Chen Kun, Gu Heng, Li Benjamin Xiao Yi

机构信息

Affiliated Hospital for Skin Disease of Chinese Academy of Medical Sciences, Nanjing, No.12, Jiangwangmiao Street, Nanjing, 210042, Jiangsu, People's Republic of China.

The Second Affiliated Hospital of GuangZhou Medical University, Gangzhou, Guangdong, 250 Changgang East Road, Haizhu District, Guangzhou, 510000, Guangdong, People's Republic of China.

出版信息

Dermatol Ther (Heidelb). 2024 Nov;14(11):3097-3112. doi: 10.1007/s13555-024-01286-x. Epub 2024 Nov 1.

DOI:10.1007/s13555-024-01286-x
PMID:39487326
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11557804/
Abstract

BACKGROUND

Combination therapy is required for the treatment of moderate acne vulgaris. However, patient compliance in applying multiple topical formulations is poor.

OBJECTIVE

To assess the efficacy and safety of a fixed-dose combination gel with adapalene 0.1% and clindamycin 1% (adapalene-clindamycin) relative to adapalene 0.1% monotherapy and clindamycin 1% monotherapy in patients with moderate facial acne vulgaris.

METHODS

This was a randomized, controlled, assessor-blind, phase III study conducted in patients with moderate facial acne vulgaris.

RESULTS

A total of 1617 patients were enrolled. At week 12, patients in the adapalene-clindamycin gel treatment group showed a significant reduction in the percentage change from baseline in total lesion count (- 66.85%), compared with adapalene alone (- 50.82%) or clindamycin gel alone (- 57.61%). The difference in the least square means of the adapalene-clindamycin gel group and adapalene group, or clindamycin gel group was - 16.08% (95% CI - 19.95% to - 12.21%) and - 9.38% (95% CI - 13.25% to - 5.51%;), respectively. At week 12, 19.28% of participants who received adapalene-clindamycin gel achieved at least 2-grade improvement in IGA, versus 7.74% with adapalene gel (OR 3.05, 95% CI 1.93, 4.80) and 14.77% with clindamycin gel (OR 1.42, 95% CI 0.97, 2.07). The study also achieved all its secondary endpoints. Adverse event rates were mostly mild to moderate and comparable across the three treatment groups.

CONCLUSION

Adapalene 0.1%-clindamycin 1% combination gel is well tolerated and demonstrated superior efficacy over 0.1% adapalene gel monotherapy and 1% clindamycin gel monotherapy for the treatment of moderate acne vulgaris.

TRIAL REGISTRATION

ClinicalTrials.gov identifier NCT03615768.

摘要

背景

中度寻常痤疮的治疗需要联合治疗。然而，患者对多种外用制剂的依从性较差。

目的

评估0.1%阿达帕林和1%克林霉素固定剂量复方凝胶（阿达帕林-克林霉素）相对于0.1%阿达帕林单药治疗和1%克林霉素单药治疗对中度面部寻常痤疮患者的疗效和安全性。

方法

这是一项针对中度面部寻常痤疮患者进行的随机、对照、评估者盲法III期研究。

结果

共纳入1617例患者。在第12周时，阿达帕林-克林霉素凝胶治疗组患者的总皮损计数较基线的百分比变化显著降低（-66.85%），相比之下，单用阿达帕林组为（-50.82%），单用克林霉素凝胶组为（-57.61%）。阿达帕林-克林霉素凝胶组与阿达帕林组或克林霉素凝胶组的最小二乘均值差异分别为-16.08%（95%CI -19.95%至-12.21%）和-9.38%（95%CI -13.25%至-5.51%）。在第12周时，接受阿达帕林-克林霉素凝胶治疗的参与者中有19.28%实现了IGA至少2级改善，而使用阿达帕林凝胶的为7.74%（OR 3.05，95%CI 1.93，4.80），使用克林霉素凝胶的为14.77%（OR 1.42，95%CI 0.97，2.07）。该研究还达到了所有次要终点。不良事件发生率大多为轻至中度，三个治疗组相当。

结论

0.1%阿达帕林-1%克林霉素复方凝胶耐受性良好，在治疗中度寻常痤疮方面显示出优于0.1%阿达帕林凝胶单药治疗和1%克林霉素凝胶单药治疗的疗效。

试验注册

ClinicalTrials.gov标识符NCT03615768。

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本文引用的文献

1
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2
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J Cosmet Dermatol. 2018 Apr;17(2):227-231. doi: 10.1111/jocd.12497. Epub 2018 Jan 30.
3
Practical management of acne for clinicians: An international consensus from the Global Alliance to Improve Outcomes in Acne.
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J Am Acad Dermatol. 2018 Feb;78(2 Suppl 1):S1-S23.e1. doi: 10.1016/j.jaad.2017.09.078. Epub 2017 Nov 8.
4
Guidelines of care for the management of acne vulgaris.寻常痤疮治疗的指南。
J Am Acad Dermatol. 2016 May;74(5):945-73.e33. doi: 10.1016/j.jaad.2015.12.037. Epub 2016 Feb 17.
5
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6
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10
Prevalence of acne vulgaris in Chinese adolescents and adults: a community-based study of 17,345 subjects in six cities.中国青少年及成年人痤疮患病率的一项基于社区的研究：六城市 17345 例患者。
Acta Derm Venereol. 2012 Jan;92(1):40-4. doi: 10.2340/00015555-1164.