Actively Recruiting
Tolerability of 532 nm Laser Treatment for Port Wine Stains Evaluating Single High-Intensity Pulse Versus Multiple Low-Intensity Pulses Using the DermaV Laser in Adults Aged 18 to 75
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
Researchers are studying the treatment of port wine birthmarks using an FDA-approved 532 nm 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 fluence laser pulse (the standard method) and multiple low fluence pulses. This clinical trial focuses on non-facial port wine stains covering at least 30 cm2 in adults aged 18 to 75 years with various skin types. Participants will receive three monthly laser treatments. Each birthmark area will be divided, with part treated using the standard single-pulse high fluence approach and other parts treated with multiple low fluence pulses. The laser used is the DermaV 532 nm device, and treatments will be carefully monitored to compare these two approaches. Throughout the study, participants must adhere to treatment schedules and post-treatment care instructions, including limited sun exposure and daily use of sunscreen on the treated area. Digital photographs will be taken for evaluation and potential educational or marketing use. The main outcome measured is the degree of improvement after six months. Safety and tolerability will be regularly assessed, and participants will be followed through the treatment and follow-up periods to monitor results and any side effects.
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
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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
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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