Treatment of Erythematotelangiectatic Rosacea With Collateral Puncture Therapy: Protocol for a Randomized Controlled Trial.

Abstract

Background: Erythematotelangiectatic rosacea (ETR) is the most common subtype of rosacea, characterized by persistent facial erythema and telangiectasia of varying calibers. It causes significant aesthetic impairment and is often accompanied by uncomfortable symptoms, such as burning, stinging, dryness, and itching, profoundly affecting patients' quality of life. Intense pulsed light (IPL) therapy demonstrates notable improvement in persistent erythema and telangiectasia; however, it is associated with issues such as a prolonged treatment course and high costs. Collateral puncture therapy involves rapid puncturing of specific acupuncture points followed by gentle squeezing around the needle holes to induce minor bleeding. Previous studies have shown that collateral puncture therapy for ETR offers advantages such as rapid onset of effect, a simple procedure, and low cost. Nevertheless, more high-quality clinical research data are needed to confirm these findings.

Objective: This study aims to observe the clinical efficacy and safety of collateral puncture therapy in treating ETR.

Methods: This study enrolled 60 patients diagnosed with ETR. The patients were randomly divided into 2 groups: one group underwent 4 sessions of collateral puncture therapy with 1-week intervals between treatments, and the other group received a single session of IPL therapy. The primary efficacy end points were the clinician's erythema assessment and the clinician's telangiectasia assessment. The secondary efficacy end points included the investigator's global assessment, patient's self-assessment, Flushing Assessment Tool results, Dermatology Life Quality Index, and Rosacea-specific Quality-of-Life instrument. The evaluation points were before treatment, immediately after treatment, and during follow-up. The data were statistically analyzed using SPSS (version 25.0; IBM Corp) to compare intragroup and intergroup differences between the 2 sets of data before and after treatment, with a significance level of α=.05 for hypothesis testing.

Results: Recruitment began on June 1, 2023. All participants have been recruited. Data analysis will be complete by the end of August 2025, with study findings available by December 2025.

Conclusions: This study has the potential to verify the clinical efficacy and safety of collateral puncture therapy in the treatment of ETR, supplement rosacea treatment methods, standardize treatment protocols, and fill a current clinical gap in treating rosacea.

Trial registration: Chinese Clinical Trial Registry ChiCTR2200062639; https://www.chictr.org.cn/showproj.html?proj=177100.

International registered report identifier (irrid): DERR1-10.2196/59682.