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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05841628
Other study ID # 2022P003297
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date December 2024

Study information

Verified date March 2024
Source Massachusetts General Hospital
Contact Cemre Turk, MD
Phone 6175133337
Email cturk@mgh.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Wellman Center for Photomedicine, Harvard Medical School Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Degree of improvement For each treatment area within the port wine stain, a blinded investigator will assess improvement (0 - 25%, 26 - 50%, 51 - 75%, 76 - 100%) 6 months
Secondary Subject satisfaction For each treatment area within the port wine stain, subject will assess satisfaction on a 1-4 scale 6 months
Secondary Side effects subject and treating physician will assess side effects of treatment including pain, swelling, skin discoloration, scar 6 months
See also
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