Oral dapsone in refractory rosacea: A prospective exploratory study defining a “high inflammatory burden” subtype and a testable precision treatment hypothesis - 08/05/26

Doi : 10.1016/j.jaad.2026.04.020

Bingyang Xu, MD ^a, Haochen Liu, MPH ^b, Yan Yang, MD ^a, Yuxin Qing, MD ^a, Yuanqin Wang, MD ^c, Tong Xiao, PhD ^a, Peiwen Yang, MD ^a, Biao Yu, MD ^d, Shengxiang Xiao, PhD ^a, Yumin Xia, PhD ^a, Tianxiao Zhang, PhD ^b,^⁎ , Jiawen Wu, PhD ^a,^⁎

^a Department of Dermatology, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China

^b Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, China

^c Department of Clinical Medicine, The Second School of Clinical Medicine, Xi’an Jiaotong University Health Science Center, Xi’an, Shaanxi, China

^d Department of Dermatology, Taihe Hospital, Hubei University of Medicine, Shiyan, China

^∗ Correspondence to: Jiawen Wu, PhD, Department of Dermatology, The Second Affiliated Hospital of Xi'an Jiaotong University, No. 157 Xiwu Rd, Xincheng District, Xi’an City, Shaanxi Province 710004, China. Department of Dermatology The Second Affiliated Hospital of Xi'an Jiaotong University No. 157 Xiwu Rd Xincheng District Xi’an City Shaanxi Province 710004 China ^∗∗ Tianxiao Zhang, PhD, Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, No. 76 Yanta West Rd, Xi'an, Shaanxi, China. Department of Epidemiology and Biostatistics School of Public Health Xi'an Jiaotong University Health Science Center No. 76 Yanta West Rd Xi'an Shaanxi China

Sous presse. Épreuves corrigées par l'auteur. Disponible en ligne depuis le Friday 08 May 2026

Abstract

Background

Refractory rosacea lacks evidence-based management.

Objective

To preliminarily assess oral dapsone outcomes in strictly defined refractory rosacea, explore mechanisms via proteomics, and generate a testable subtyping hypothesis.

Methods

This prospective, single-center, single-arm exploratory trial enrolled 124 refractory rosacea patients. Patients received dapsone 100 mg daily for 8 weeks. A nested substudy ( N = 28) collected stratum corneum for proteomics. Using proteomic and clinical data, we defined a “high inflammatory burden” subtype and explored its association with treatment response.

Results

Patients failed a mean of 3.2 prior treatments. At week 8, 59.68% achieved Investigator Global Assessment 0/1. 82.26% achieved “deep remission” (both Investigator Global Assessment and Clinician Erythema Assessment improved)—a finding requiring interpretation within potential placebo effects (20% to 45%). Proteomics revealed 33 downregulated inflammation-related proteins. The “high inflammatory burden” subtype (54.03%) showed higher deep remission (88.06% vs 75.44%), absolute difference 12.62% (OR = 2.40, 95% CI: 0.925-6.23; P = .110), not reaching significance.

Limitations

Single-center, single-arm design.

Conclusion

This exploratory study observed clinical improvements with oral dapsone in refractory rosacea and generated a testable hypothesis: the “high inflammatory burden” subtype may identify patients more likely to benefit. Providing a clear subtype definition, effect size estimates, and enrichment trial design, this study offers an actionable framework for future validation trials.

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Key words : clinical subtypes, dapsone, proteomics, rosacea

Abbreviations used : CEA, IGA, IL-17

Plan

	Dr Xu and Author Liu contributed equally to this work.
	Funding sources: This study was supported by the IIT Clinical Research Fund of The Second Affiliated Hospital of Xi'an Jiaotong University (grant no. 2025IIT-M06 ).
	Patient consent: The patients in this manuscript have given written informed consent to the publication of their case details.
	IRB approval status: This study was approved by the Ethics Committee of the Second Affiliated Hospital of Xi'an Jiaotong University (Approval no. 2025168).
	Data availability statement: The data that support the findings of this study are available from the corresponding author upon reasonable request.