Tolerability of 532 nm Laser Treatment of Port Wine Stains
ConditionPort-Wine Stain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
Qualifiers
.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.
Disqualifiers
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.
Any type of prior cosmetic or port wine stain treatment to the target area within 3 months of study participation.
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).
Pregnant and/or breastfeeding, or planning to become pregnant.
Trial design
Treatments tested in this trial
- 532 nm laser treatment
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov