15 Participants Needed

Laser Treatment for Port-Wine Stains

CT
Overseen ByCemre Turk, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a laser treatment for port-wine birthmarks, which are red or purple marks on the skin. Researchers aim to assess how well participants tolerate the 532 nm laser treatment and whether different laser application methods are more effective. Specifically, they compare the usual single strong laser pulse to multiple weaker pulses on different parts of the birthmark. Candidates may qualify if they have a port-wine stain at least the size of a large handprint (30 cm²), not located on the face, and are willing to follow treatment and care instructions. As an unphased trial, this study offers a unique opportunity to explore innovative treatment methods for port-wine birthmarks.

What prior data suggests that this laser treatment is safe for port-wine stains?

Studies have shown that the 532 nm laser is safe and effective for treating port-wine stains, which are red or purple birthmarks caused by extra blood vessels. Research indicates that patients generally tolerate the laser treatment well. Reports of serious side effects are few. Most patients experience only mild reactions, such as temporary redness or swelling in the treated area. This makes the 532 nm laser a trusted option for managing these types of birthmarks.12345

Why are researchers excited about this trial?

Researchers are excited about the 532 nm laser treatment for port-wine stains because it offers a new approach by using different settings to target the affected skin. Traditional treatments, like pulsed dye lasers, typically use a single high-intensity pulse, which can sometimes cause more discomfort or require longer recovery times. This new laser method uses multi-pulse low fluence settings, potentially reducing side effects and improving comfort during treatment. Additionally, the ability to adjust the laser settings might lead to more personalized and effective treatment outcomes for individuals with port-wine stains.

What evidence suggests that this laser treatment is effective for port-wine stains?

Research has shown that laser treatments can reduce the appearance of port-wine stains, a type of birthmark caused by unusual blood vessels. Studies have found that the 532 nm laser, tested in this trial, can lighten these birthmarks by targeting the blood vessels under the skin. Before-and-after photos from past treatments demonstrate noticeable improvement after just one session. While results can vary, especially depending on the body part, many people see a significant reduction in redness. In some cases, areas like the arms and legs may not respond as well as the face and neck. Overall, the 532 nm laser offers a promising option for those looking to improve the appearance of port-wine stains.12346

Who Is on the Research Team?

YL

Yakir Levin, MD, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with non-facial port wine stains covering at least a 30cm2 area. Participants must be able to follow the study's procedures and care instructions, limit sun exposure, and use sunscreen daily. Pregnant or breastfeeding women, those planning pregnancy, or individuals with certain skin conditions or sensitivities are excluded.

Inclusion Criteria

People with any skin type can participate.
I have a port wine stain not on my face that covers at least 30cm2.
I won't have cosmetic treatments on the study areas during the trial.
See 5 more

Exclusion Criteria

You have a history of unusual scarring or healing, or you bruise easily.
You are very sensitive to light.
You have a history of skin color changes that the study doctor doesn't think is okay for this study.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 3 monthly laser treatments with the 532 nm DermaV laser, using both single-pulse high fluence and multiple-pulse low fluence approaches

3 months
3 visits (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and side effects after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • 532 nm laser treatment
Trial Overview The study tests the tolerability of an FDA-approved 532 nm laser treatment on port wine stains using two methods: standard single-pulse high fluence and multiple-pulse low fluence. Participants will receive three monthly treatments to compare these approaches.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Port wine stainExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/16425790/
[Own clinical experience in treatment of port-wine stain with ...The results of treatment was poor in 74% of malformations which were located beyond the face and neck (all of them were on the limbs). There was no episodes of ...
Retrospective analysis of the correlation between ...... malformations; or (3) with prior treatment history. Due to the lack of ... PWS is the most common capillary malformation, and it presents with well ...
Treatment of Port‐Wine Birthmarks Using a Large‐Spot ...Port-wine birthmarks (PWBs) are congenital vascular malformations, caused by ectatic capillaries and postcapillary venules [1, 2]. PWBs ...
Full article: Laser treatment of port-wine stainsNotes: The capillary malformation is shown before treatment (A) and after one session of 532 nm potassium titanyl phosphate laser treatment (B).
KTP Laser vs Pulsed Dye Laser for Port-Wine StainsNevus flammeus is a vascular, primarily capillary malformation visible from birth on. In rare cases, it may also affect venous and/or arterial vascular ...
A Systematic Review and Meta-AnalysesThe objective of this systematic review was to review the effectiveness and safety of recognized therapies for untreated capillary malformations ...
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