NCT05841628

Tolerability of 532 nm Laser Treatment of Port Wine Stains

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	532 nm laser treatment	The port wine birthmark will be treated with the DermaV 532 nm laser.

Timeline

• Start date: 2023-05-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-05-03
• Last updated: 2025-11-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study