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

Nanjing Medical University

Status: Completed

Conditions: Rosacea; Pulsed Dye Laser

Treatments: Device: pulse duration, 6ms; Device: pulse duration, 10ms

Study type: Interventional

Funder types: Other

Identifiers

NCT07410533

2025-SR-1016

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

6ms-pulse group

Active Comparator group

Treatment:

Device: pulse duration, 6ms

10ms-pulse group

Experimental group

Treatment:

Device: pulse duration, 10ms