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CompletedNCT07410533Updated Feb 17, 2026

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

An interventional study of pulse duration, 6ms and pulse duration, 10ms in Pulsed Dye Laser and Rosacea, sponsored by The First Affiliated Hospital with Nanjing Medical University. Completed at 1 site in China. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-02-17.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Feb 2025, registered Feb 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pulsed Dye Laser
  • Rosacea

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03

In context

Rosacea

233 studies on the registry are indexed under Rosacea; 23 are open to participants now.

This study's enrollment of 80 is above the median of 61 across 200 interventional studies indexed under Rosacea.

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Lead sponsor

The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 568 studies on the registry; 317 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    6ms-pulse group

    Device: pulse duration, 6ms

  • Experimental
    10ms-pulse group

    Device: pulse duration, 10ms

Interventions

  • Devicepulse 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.

  • Devicepulse 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.

06

What researchers measure

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

    Time frame: From enrollment to the end of treatment at 4 weeks

07

Study locations

1 site
  • the First Affiliated Hospital of Nanjing Medical University
    Nanjing, Jiangsu 210000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07410533
Responsible party
Sponsor
First posted
Feb 13, 2026
Start date
Feb 1, 2025
Primary completion
Nov 30, 2025
Completion
Nov 30, 2025
Last update
Feb 17, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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