Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 532 nm laser treatment

    Device

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

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Port wine stainExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Source ClinicalTrials.gov
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