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
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- Female or male aged 18 to 75 years inclusive
- Fitzpatrick Skin Type I to VI
- Have a non-facial port wine stain covering at least 30 cm2 on the body
- Willing to undergo Lutronic DermaV 532 nm laser treatments and adhere to treatment and follow-up schedules
- Willing to limit sun exposure and use sunscreen daily on the treatment area throughout the study
- Agree to have digital photos taken of the treatment area for educational, publication, or marketing use
- Agree not to have any 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...
- Participated in another clinical trial with a drug or device on the treatment area within 3 months before or during this study
- Had any cosmetic or port wine stain treatment to the target area within 3 months before the study
- Have significant or inflammatory skin conditions on the treated area, such as open wounds, rash, infection, or dermatitis
- Pregnant, breastfeeding, or planning pregnancy
- Have serious illnesses like diabetes, immune disorders, or are using immunosuppressive medications
- Sensitive to light exposure or taking medications that increase light sensitivity
- History of keloid or hypertrophic scarring, abnormal wound healing, or prone to bruising
- History of skin cancers like squamous cell carcinoma or melanoma in the treatment area
- History of skin disorders affecting collagen or blood vessels, including collagen vascular or vasculitic diseases
- Any active skin condition that might interfere with treatment as judged by the investigator
- History of connective tissue diseases such as lupus or scleroderma
- History of heat-stimulated diseases like recurrent herpes simplex or shingles in the treatment area unless treated preventively
- History of pigmentary disorders causing unacceptable skin color changes
- Excessive tanning or sunburn in the treatment area and unable to avoid tanning during the study
- Excessive hair in the treatment area interfering with assessment or treatment
- Any physical or mental condition that could make participation unsafe or affect compliance, including substance abuse
AI-Screening
AI-Powered Screening
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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
CONTACT
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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