An interventional study of 532 nm laser treatment in Port-Wine Stain, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-26.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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:
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.
79 studies on the registry are indexed under Port-Wine Stain; 7 are open to participants now.
This study's planned enrollment of 15 is below the median of 30 across 53 interventional studies indexed under Port-Wine Stain.
Browse Port-Wine Stain studies →Massachusetts General Hospital is the lead sponsor of 2,537 studies on the registry; 447 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
6. Willing to have very limited sun exposure and use sunscreen on the treatment area every day for the duration of the study, including the follow-up period.
7. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation (educational and/or marketing), publications, and any additional marketing purposes.
8. Agree to not undergo any other cosmetic procedure(s) or treatment(s) on the treated areas during the study and has no intention of having such procedures performed during the course of the study.
9. For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study.,
Exclusion Criteria:
The port wine stain will be treated with the DermaV laser. Within the single port wine stain, one area will be treated with standard settings (single pulse high fluence). Four other areas will be treated with multi-pulse low fluence settings. A sixth area will be an untreated control.
Device: 532 nm laser treatment
The port wine birthmark will be treated with the DermaV 532 nm laser.
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%)
Time frame: 6 months
Subject satisfaction
For each treatment area within the port wine stain, subject will assess satisfaction on a 1-4 scale
Time frame: 6 months
Side effects
subject and treating physician will assess side effects of treatment including pain, swelling, skin discoloration, scar
Time frame: 6 months
Plan to share: No — Individual participant data will not be shared for this pilot study.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Massachusetts General Hospital