Actively Recruiting
Tolerability of 532 nm Laser Treatment of Port Wine Stains
Led by Massachusetts General Hospital · Updated on 2025-11-26
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the treatment of port wine birthmarks using an FDA-approved 532 nm laser, called the DermaV laser. The study aims to understand how well the treatments are tolerated and whether there are differences in tolerability and results between using a single high energy laser pulse versus multiple low energy pulses. Participants have non-facial port wine stains covering at least 30 cm2 on their body and are adults aged 18 to 75 years. Participants will receive three monthly laser treatments on their port wine birthmarks. Within each treated birthmark, one area will be treated with the standard single high fluence (high energy) pulse, while four other areas will receive multiple low fluence (lower energy) pulses. A sixth area of the birthmark will not be treated and will serve as a control for comparison. The study focuses on comparing these different laser pulse approaches during the treatment period. During the study, participants will be monitored for improvement in the treated areas at six months. Researchers will assess the degree of improvement, participant satisfaction, and any side effects. Participants are asked to follow post-treatment care, limit sun exposure by using sunscreen daily, and attend follow-up visits for evaluation. Digital photographs of the treatment areas will be taken to document results and support study analysis.
CONDITIONS
Brief Title
Tolerability of 532 nm Laser Treatment of Port Wine Stains
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to read, understand, and sign the informed consent form
- Male or female aged 18 to 75 years inclusive
- Fitzpatrick Skin Type I to VI
- Non-facial port wine stain covering at least 30 cm2 on the body
- Willing to receive Lutronic DermaV 532 nm laser treatments and follow all study visits and post-treatment care
- Willing to limit sun exposure and use sunscreen daily on the treatment area during the study and follow-up
- Agree to have digital photographs taken and used for educational, publication, or marketing purposes
- Agree not to have other cosmetic procedures or treatments on the treated areas during the study
- For females: not pregnant or lactating and either post-menopausal, surgically sterilized, or using acceptable birth control at least 3 months before and during the study
You will not qualify if you...
- Participation in another clinical trial with a drug or device on the treatment area within 3 months before or during this study
- Prior cosmetic or port wine stain treatment to the target area within 3 months before participation
- Significant skin conditions or inflammation (open wounds, rash, infection, dermatitis) in the treated area before treatment
- Pregnant, breastfeeding, or planning pregnancy
- Significant illness such as diabetes, immune deficiency, or use of immunosuppressive drugs
- Hypersensitivity to light exposure
- Use of medication increasing light sensitivity
- History of keloid or hypertrophic scarring or abnormal wound healing
- History of skin cancer (squamous cell carcinoma or melanoma) in the treatment area
- History of skin or connective tissue disorders affecting collagen or blood vessels
- Active skin conditions that may interfere with treatment
- History of diseases triggered by heat (like herpes simplex or shingles) unless treated preventively
- History of pigment disorders causing abnormal skin color changes
- Excessive tanning or inability to avoid tanning during the study
- Excessive hair in the treatment area interfering with assessment
- Any physical or mental condition that may make participation unsafe or limit compliance as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session
Participants receive 532 nm laser treatment on port wine stains with different settings applied to various areas, including untreated control areas.
1 treatment visit (in-person)
Duration - 6 months
Participants are monitored for side effects and treatment outcomes including degree of improvement and satisfaction.
Multiple follow-up visits during 6 months
Trial Site Locations
Total: 1 location
1
Wellman Center for Photomedicine, Harvard Medical School
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
C
Cemre Turk, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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