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RecruitingNCT05841628Updated Nov 26, 2025

Tolerability of 532 nm Laser Treatment of Port Wine Stains

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

From the registry’s dates

  • Started May 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

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.

02

Conditions studied

  • Port-Wine Stain

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03

In context

Port-Wine Stain

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Port wine stain

    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

Interventions

  • Device532 nm laser treatment

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

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Subject satisfaction

    For each treatment area within the port wine stain, subject will assess satisfaction on a 1-4 scale

    Time frame: 6 months

  2. Side effects

    subject and treating physician will assess side effects of treatment including pain, swelling, skin discoloration, scar

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Wellman Center for Photomedicine, Harvard Medical School
    Boston, Massachusetts 02114, United States
    • Beverly Dammin · Contact · 617-726-3008
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared for this pilot study.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05841628
Lead sponsor
Massachusetts General Hospital
Responsible party
Yakir Levin, MD, PhD (Instructor, Harvard Medical School, Massachusetts General Hospital) — Principal investigator
First posted
May 3, 2023
Start date
May 1, 2023
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Nov 26, 2025

Study contacts

Cemre Turk, MD
Contact
cturk@mgh.harvard.edu
6175133337
Yakir Levin, MD, PhD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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