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Tolerability of 532 nm Laser Treatment of Port Wine Stains

NCT05841628 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-11-26

No results posted yet for this study

Summary

The goal of this study is to learn about treatment of port wine birthmarks treated with an FDA-approved 532 nm laser.

The main questions it aims to answer are:

* How well are the treatments tolerated?
* Are there differences in tolerability of the treatment when a single high fluence laser pulse is used (the standard treatment) versus using multiple low fluence pulses?
* Are there differences in results when using a single high fluence pulse versus multiple low fluence pulses?

type of study: Clinical Trial

Participants will undergo 3 monthly laser treatments with the 532 nm DermaV laser. Part of their birthmark will be treated with the standard single-pulse high fluence approach, and other parts will be treated with the multiple-pulse low fluence approach.

Conditions

  • Port-Wine Stain

Interventions

DEVICE

532 nm laser treatment

The port wine birthmark will be treated with the DermaV 532 nm laser.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Yakir Levin, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05841628 on ClinicalTrials.gov