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

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

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.

Study Overview

• Status: Completed
• Conditions: Rosacea; Pulsed Dye Laser
• Intervention / Treatment: Device: pulse duration, 6ms; Device: pulse duration, 10ms

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• participants aged 20-60 years with a clinical diagnosis of erythematotelangiectatic rosacea, in otherwise good general health, who provided written informed consent and agreed to complete the study procedures.

Exclusion Criteria:

1. active infection at the treatment site;
2. a history of keloid formation or a tendency to develop keloids;
3. a history of photosensitivity disorders;
4. facial laser treatment, chemical peeling, or facial surgery within the past 3 months;
5. pregnancy or breastfeeding;
6. concomitant treatment for rosacea;
7. participation in another clinical trial within 30 days prior to screening;
8. any other condition deemed by the investigator to make the subject unsuitable for participation;
9. presence of other facial inflammatory skin diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 6ms-pulse group	Device: pulse duration, 6ms; The PDL (595 nm, VBeam, Candela/Syneron, Wayland, MA) settings were: Energy range, 9-11 J/cm2[Y7.1]; spot size, 7 mm; pulse duration, 6ms; with a dynamic spray cooling device was used during this study.
Experimental: 10ms-pulse group	Device: pulse duration, 10ms; The PDL (595 nm, VBeam, Candela/Syneron, Wayland, MA) settings were: Energy range, 9-11 J/cm2[Y7.1]; spot size, 7 mm; pulse duration, 10ms; with a dynamic spray cooling device was used during this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Erythema Assessment (CEA) score	Clinician's Erythema Assessment (CEA) scale Scores 0= clear Clear skin with no signs of erythema 1 = Almost clear Slight redness; almost clear 2=mild Definite redness; mild erythema 3 = moderate Marked redness; moderate erythema 4= severe Fiery redness; severe erythema This scale assesses the average facial erythema condition over 24 hours.For CEA scoring, which were evaluated masked by two well-trained dermatologists. when two dermatologists have different scores, the one with the higher score will be included in the statistics	From enrollment to the end of treatment at 4 weeks

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Actual): November 30, 2025
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: February 8, 2026
• First Submitted That Met QC Criteria: February 8, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin and Connective Tissue Diseases; Rosacea
• Other Study ID Numbers: 2025-SR-1016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No