Treatment of port wine birthmarks with a laser
Official title: Tolerability of 532 nm Laser Treatment of Port Wine Stains
Run by Massachusetts General Hospital · NCT05841628 · Data updated 2026-11-12
This study is testing a laser treatment for port wine birthmarks to see which method works better and is easier for patients to handle.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | May 1, 2023 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | November 26, 2025 |
| Trial ID | NCT05841628 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 75 with non-facial port wine stains covering at least 30 cm².
✕Probably not a fit
Patients with facial port wine stains or those who cannot adhere to treatment protocols may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the tolerability of an FDA-approved 532 nm laser treatment for port wine stains. Participants will receive three monthly treatments, with some areas treated using a standard single high fluence pulse and others with multiple low fluence pulses. The study aims to compare the tolerability and effectiveness of these two approaches in treating the birthmarks.
Why it matters
Potential benefit: If successful, this treatment could provide a more tolerable and effective option for patients with port wine stains.
How similar studies have gone: Previous studies have shown promise in laser treatments for port wine stains, but this specific comparison of treatment approaches is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. .Subject must be able to read, understand and sign the Informed Consent Form. 2. Female or Male, 18 to 75 years of age (inclusive). 3. Fitzpatrick Skin Type I - VI. 4. Have non-facial port wine stain covering at least 30cm2 area on the body. 5. Must be willing to have Lutronic DermaV treatments (532 nm) and able to adhere to the treatments, follow-up visit schedule, and post-treatment care instructions. 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: 1. Participation in a clinical trial of another drug, or device administered to the treatment area, within 3 months prior to enrollment or during the study. 2. Any type of prior cosmetic or port wine stain treatment to the target area within 3 months of study participation. 3. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including but not limited to, open lacerations or abrasions, hidradenitis, rash, infection , or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion). 4. Pregnant and/or breastfeeding, or planning to become pregnant. 5. Significant concurrent illness, such as diabetes mellitus, immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or using immunosuppressive medication. 6. Hypersensitivity to light exposure. 7. Any use of medication that is known to increase sensitivity to light according to the Investigator's discretion. 8. History of keloid scarring, hypertrophic scarring or abnormal wound healing or prone to bruising. 9. Has a history of squamous cell carcinoma or melanoma in the treatment area. 10. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders. 11. A history or active skin condition that in the opinion of the Investigator may interfere/confound with the treatment. 12. History of connective tissue disease, such as systemic lupus erythematosus or scleroderma. 13. History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen. 14. History of pigmentary disorders, particularly tendency for hyper- or hypo- pigmentation, or any that are considered not acceptable by the study investigator. 15. Excessively tanned or active sun tan in area to be treated, or unable/unlikely to refrain from tanning during the study. 16. Excessive hair in the area to be treated (beards, sideburns, and/or moustache,) that would interfere with diagnosis, assessment, and treatment. 17. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study, including excessive alcohol or drug abuses, or a condition that would compromise the subject's ability to comply with the study requirements.
Where it's running
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Wellman Center for Photomedicine, Harvard Medical School
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Yakir Levin, MD, PhD — Massachusetts General Hospital
- Study coordinator: Cemre Turk, MD
- Email: cturk@mgh.harvard.edu
- Phone: 6175133337
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Evaluating Light Dose for Treating Port-Wine Birthmarks with Hemoporfin PDT
This study is testing how well a new light treatment using Hemoporfin can help people with port-wine birthmarks on their face and neck.
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Comparing pulsed dye, KTP, and sequential KTP→PDL laser treatment for port‑wine stains
This study will try pulsed dye laser, KTP laser, and a sequential KTP then PDL approach on different parts of your port‑wine stain to see which lightens the lesion best and is most tolerable.
-
Maximizing laser therapy success for Port-Wine Birthmarks in kids
This study tests different laser treatment sequences to see which approach clears Port-Wine Stains in children with fewer sessions and less need for anesthesia.
-
ADVATx laser treatment for port-wine stains (vascular birthmarks)
This project will test whether four monthly ADVATx laser treatments can lighten port-wine stains in people with lesions at least 15 cm² and Fitzpatrick skin types I–IV.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.