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

NCT07410533 | Completed DMC

• 1 other identifier: 2025-SR-1016
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulsed Dye Laser; Rosacea

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

6ms-pulse group

ACTIVE COMPARATOR

Device: pulse duration, 6ms

10ms-pulse group

EXPERIMENTAL

Device: pulse duration, 10ms

Interventions

pulse duration, 6ms DEVICE

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.

6ms-pulse group

pulse duration, 10ms DEVICE

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.

10ms-pulse group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: February 13, 2026
• Study Start: February 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

CN (1)