Analysis of Factors Associated With the Efficacy of 595-nm Pulsed Dye Laser Treatment for Rosacea

This study was designed as a single-center, prospective, randomized controlled trial and included 80 patients with rosacea treated at the Department of Dermatology, Jiangsu Provincial People's Hospital. All patients received pulsed dye laser therapy (pulsed dye laser system; Cynosure (Beijing) Medical Technology Co., Ltd., China). Treatment energy was adjusted according to individual clinical responses, with no concomitant therapies administered. All patients were informed of study-related precautions and provided written informed consent prior to enrollment. Each patient underwent a single session of bilateral facial 595-nm pulsed dye laser treatment with randomized pulse durations of 6 ms or 10 ms, using a fluence of 9-11 J/cm² and a 7-mm spot size, followed by post-treatment epidermal cooling. Skin imaging was performed at baseline and at 1 month after treatment. At 3 and 7 days post-treatment, erythema improvement, pain visual analog scale (VAS) scores, and adverse events were assessed using questionnaires. At 1 month, treatment efficacy and safety were evaluated based on erythema improvement, patient satisfaction, Clinical Erythema Assessment (CEA) score, Investigator's Global Assessment (IGA) score, Rosacea Area and Severity Index (RASI) score, skin imaging analysis, and adverse event records.

NCT Number	NCT07410533
Lead Sponsor	The First Affiliated Hospital with Nanjing Medical University
Conditions	Pulsed Dye Laser, Rosacea
Enrollment	80 participants
Start Date	2025-02-01
Primary Completion	2025-11-30 (estimated)
Study Completion	2025-11-30 (estimated)
Updated on ClinicalTrials.gov	2026-02-17