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.

IF 3.5 3区医学 Q1 DERMATOLOGY

Dermatology and Therapy Pub Date : 2024-11-01 DOI:10.1007/s13555-024-01286-x

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

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引用次数: 0

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.

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阿达帕林 0.1%和克林霉素 1%固定剂量复方凝胶治疗大疱性痤疮（CACTUS）的有效性和安全性：一项随机、对照、评估者盲法的 III 期临床试验。

背景：治疗中度寻常型痤疮需要联合疗法。然而，患者对使用多种外用制剂的依从性很差：评估阿达帕林 0.1%和克林霉素 1%（阿达帕林-克林霉素）固定剂量联合凝胶相对于阿达帕林 0.1%单药治疗和克林霉素 1%单药治疗对中度面部寻常痤疮患者的疗效和安全性：这是一项在中度面部寻常型痤疮患者中开展的随机对照、评估者盲法III期研究：结果：共有 1617 名患者参加了研究。第12周时，阿达帕林-克林霉素凝胶治疗组患者的皮损总数与基线相比的百分比变化显著减少（-66.85%），而单独使用阿达帕林（-50.82%）或单独使用克林霉素凝胶（-57.61%）的患者的皮损总数与基线相比的百分比变化显著减少。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平方均值差异分别为-16.08%（95% CI - 19.95%至-12.21%）和-9.38%（95% CI - 13.25%至-5.51%）。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%的IGA至少改善了2个等级，而接受阿达帕林凝胶治疗的参与者中有7.74%的IGA至少改善了2个等级（OR值为3.05，95% CI为1.93，4.80），接受克林霉素凝胶治疗的参与者中有14.77%的IGA至少改善了2个等级（OR值为1.42，95% CI为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度至中度，三个治疗组的不良事件发生率相当：阿达帕林0.1%-克林霉素1%联合凝胶的耐受性良好，在治疗中度寻常型痤疮方面的疗效优于阿达帕林0.1%凝胶单药治疗和克林霉素1%凝胶单药治疗：试验注册：ClinicalTrials.gov identifier NCT03615768。

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来源期刊

Dermatology and Therapy Medicine-Dermatology

CiteScore

6.00

自引率

8.80%

发文量

187

审稿时长

6 weeks

期刊介绍： Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.