Efficacy and Safety of Hydroxychloroquine Combined With Doxycycline for the Treatment of Patients With Rosacea: A Randomized, Double-Blind, Double-Dummy Clinical Trial

IF 3.4 4区医学 Q1 DERMATOLOGY

Dermatologic Therapy Pub Date : 2025-08-30 DOI:10.1155/dth/6636265

Xin Yuan, Jin Lu, Liang Sheng, Guang Shi, Xue Chen, Leiwei Jiang

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引用次数: 0

Abstract

Purpose: While the 2021 Chinese rosacea guidelines recommend hydroxychloroquine (HCQ) and doxycycline as A-level treatments for erythema, monotherapy with these agents has shown suboptimal clinical efficacy against both erythema and flushing symptoms. This study aimed to evaluate whether combination therapy could enhance therapeutic outcomes without increasing adverse effects (AEs).

Methods: In this randomized, double-blind, placebo-controlled trial conducted at Guizhou Provincial People’s Hospital (January 2022–January 2024), 73 moderate-to-severe rosacea patients were randomized to receive either (1) HCQ 200 mg bid plus doxycycline 100 mg qd (intervention group, n = 36) or (2) placebo plus doxycycline 100 mg qd (control group, n = 37). Treatment duration was 8 weeks with follow-up assessments at Weeks 0, 4, 8, and 12.

Results: Among 58 completers (29 per group), the intervention group demonstrated significantly higher clinical efficacy at Week 8: erythema improvement rates (89.67% vs. 68.97%, p < 0.05), flushing reduction (68.97% vs. 44.83%, p < 0.05), and greater quality-of-life improvement (RosQoL score Δ23.66 vs. Δ17.00, p < 0.05). Investigator’s Global Assessment showed comparable results (72.22% vs. 65%, p > 0.05). Both regimens were well tolerated with no severe AEs reported.

Conclusion: The HCQ–doxycycline combination demonstrates superior efficacy over doxycycline monotherapy for improving erythema, flushing symptoms, and quality of life in moderate-to-severe rosacea patients, with comparable safety profiles.

Trial Registration: Chinese Clinical Trial Register: ChiCTR2400089784

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羟氯喹联合强力霉素治疗酒渣鼻的疗效和安全性：一项随机、双盲、双虚拟临床试验

目的：虽然2021年中国酒渣鼻指南推荐羟氯喹（HCQ）和强力霉素作为红斑的a级治疗药物，但这些药物的单一治疗对红斑和潮红症状的临床疗效均不理想。本研究旨在评估联合治疗是否可以在不增加不良反应（ae）的情况下提高治疗效果。方法：在贵州省人民医院（2022年1月- 2024年1月）进行的随机、双盲、安慰剂对照试验中，73例中重度酒渣鼻患者随机分为(1)HCQ 200 mg bid +强力霉素100 mg qd（干预组，n = 36）或(2)安慰剂+强力霉素100 mg qd（对照组，n = 37）。治疗持续时间为8周，随访时间为第0、4、8和12周。结果：在58名完成者（每组29名）中，干预组在第8周表现出明显更高的临床疗效：红斑改好率（89.67%对68.97%,p < 0.05），潮红减少（68.97%对44.83%,p < 0.05），生活质量改善（RosQoL评分Δ23.66对Δ17.00, p < 0.05）。研究者的全球评估显示了类似的结果（72.22%对65%，p > 0.05）。两种方案均耐受良好，无严重不良反应报告。结论：hcq -强力霉素联合治疗在改善中度至重度酒渣鼻患者的红斑、潮红症状和生活质量方面优于强力霉素单药治疗，且安全性相当。试验注册：中国临床试验注册：ChiCTR2400089784

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来源期刊

Dermatologic Therapy 医学-皮肤病学

CiteScore

7.00

自引率

8.30%

发文量

711

审稿时长

3 months

期刊介绍： Dermatologic Therapy has been created to fill an important void in the dermatologic literature: the lack of a readily available source of up-to-date information on the treatment of specific cutaneous diseases and the practical application of specific treatment modalities. Each issue of the journal consists of a series of scholarly review articles written by leaders in dermatology in which they describe, in very specific terms, how they treat particular cutaneous diseases and how they use specific therapeutic agents. The information contained in each issue is so practical and detailed that the reader should be able to directly apply various treatment approaches to daily clinical situations. Because of the specific and practical nature of this publication, Dermatologic Therapy not only serves as a readily available resource for the day-to-day treatment of patients, but also as an evolving therapeutic textbook for the treatment of dermatologic diseases.