JMIR Publications

ABSTRACT

Introduction Rosacea is a chronic recurrent inflammatory disease that predominantly affects the central face, involving facial blood vessels, nerves, and the pilosebaceous units. The international prevalence rate is approximately 5.46%,1 significantly affecting patients' lives. Based on the characteristics of skin lesions, it can be categorized into four subtypes: erythematotelangiectatic, papulopustular, phymatous, and ocular types, among which erythematotelangiectatic rosacea is the most common subtype.2 This study aims to observe the clinical efficacy and safety of bloodletting therapy in treating erythematotelangiectatic rosacea. Methods and analysis This study enrolled 60 patients diagnosed with erythematotelangiectatic rosacea. The patients were randomly divided into two groups: one group underwent four sessions of bloodlettingletting therapy with one week intervals between treatments, and the other group received a single session of intense pulsed light (IPL) therapy. The primary efficacy endpoints are the Clinician’s Erythema Assessment (CEA), Doctor’s Telangiectasia Rating Scale. The secondary efficacy endpoints include the Investigator′s Global Assessment (IGA), Patient’s Self-Assessment (PSA), Flushing Symptom Questionnaire (FSQ), Dermatology Life Quality Index (DLQI), and Rosacea-Specific Quality-Of-Life Instrument (RosaQoL). Evaluation points were selected before treatment, immediately after treatment, and during follow-up. Adverse reactions during the treatment period for each patient will be collected and recorded.

Results:

This paper describes the protocol of our study. The recruitment began on 1 June 2023. All participants have been recruited. Data analysis will be complete by the end of March 2024, with study findings available by December 2024. Conclusion:This study has the potential to verify the clinical efficacy and safety of bloodletting therapy in the treatment of erythematotelangiectatic rosacea, and to supplement rosacea treatment methods, standardize treatment protocols, and fill the current clinical gap in treating rosacea. Ethics and dissemination Ethics approval was obtained from the Ethics Committee of Guang’ anmen Hospital, China Academy of Chinese Medical Sciences(2022–127-KY). The results of this study will be published in a peer-reviewed journal. Trial registration number Chinese Clinical Trial Registration Center (ChiCTR2200061943).Methods and analysis This study enrolled 60 patients diagnosed with erythematotelangiectatic rosacea. The patients were randomly divided into two groups: one group underwent four sessions of bloodlettingletting therapy with one week intervals between treatments, and the other group received a single session of intense pulsed light (IPL) therapy. The primary efficacy endpoints are the Clinician’s Erythema Assessment (CEA), Doctor’s Telangiectasia Rating Scale. The secondary efficacy endpoints include the Investigator′s Global Assessment (IGA), Patient’s Self-Assessment (PSA), Flushing Symptom Questionnaire (FSQ), Dermatology Life Quality Index (DLQI), and Rosacea-Specific Quality-Of-Life Instrument (RosaQoL). Evaluation points were selected before treatment, immediately after treatment, and during follow-up. Adverse reactions during the treatment period for each patient will be collected and recorded. Ethics and dissemination Ethics approval was obtained from the Ethics Committee of Guang’ anmen Hospital, China Academy of Chinese Medical Sciences(2022–127-KY). The results of this study will be published in a peer-reviewed journal. Trial registration number Chinese Clinical Trial Registration Center (ChiCTR2200061943).