What side effects are associated with this type of intervention?

The most common side effects of 532 nm laser treatment for Port-Wine Stain include pain during the procedure, erythema (redness), edema (swelling), and purpura (bruising). These side effects are generally temporary and subside within a few days to weeks. In some cases, there may be risks of pigmentary changes such as hyperpigmentation or hypopigmentation, and rarely, blistering or scarring can occur. Proper post-treatment care and monitoring can help mitigate these side effects.

What prior FDA approvals exist?

The FDA has approved various laser treatments for Port-Wine Stains, focusing on selective photothermolysis. One of the most commonly used lasers is the pulsed dye laser (PDL), which targets blood vessels in the skin to reduce the appearance of these vascular lesions. The 532 nm laser, as studied in the clinical trial, is another example of selective photothermolysis used to treat Port-Wine Stains. These treatments work by delivering specific wavelengths of light that are absorbed by the blood vessels, causing them to coagulate and eventually be reabsorbed by the body, thereby lightening the stain.

What other types of research exist?

Promising novel alternatives to 532 nm Laser Treatment for Port-Wine Stain patients include: 1) Pulsed Dye Laser (PDL) therapy, which has been effective in treating vascular lesions with good long-term results. 2) Intense Pulsed Light (IPL) therapy, which has shown efficacy in treating photodamaged skin and facial telangiectasias. 3) Photodynamic Therapy (PDT) using topical agents like aminolevulinic acid (ALA) or methyl aminolevulinate (MAL), which has been effective for various skin conditions and may offer benefits for vascular lesions. These alternatives provide different mechanisms of action and may offer improved outcomes or reduced side effects for some patients.

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Laser Therapy

Laser Treatment for Port-Wine Stains

N/A

Recruiting

Led By Yakir Levin, MD, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have non-facial port wine stain covering at least 30cm2 area on the body

Agree to not undergo any other cosmetic procedure(s) or treatment(s) on the treated areas during the study and has no intention of having such procedures performed during the course of the study

Must not have

History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders

Significant concurrent illness, such as diabetes mellitus, immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or using immunosuppressive medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a special laser treatment for people with port wine birthmarks. The laser works by targeting and reducing the blood vessels in the birthmark. Researchers want to see how well patients tolerate the treatment and compare two different methods of using the laser. Lasers have been used to treat port-wine stains for the past two decades, with pulsed-dye laser (PDL) being the current standard treatment.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort during treatment, redness, swelling, bruising in the treated area, changes in skin pigmentation (lighter or darker skin patches), blistering, scarring risk if prone to abnormal healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a port wine stain not on my face that covers at least 30cm2.

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I won't have cosmetic treatments on the study areas during the trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of skin or blood vessel disorders.

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I have a serious health condition like diabetes, HIV/AIDS, or I am on immunosuppressive medication.

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I haven't had cosmetic or port wine stain treatments in the last 3 months.

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I have had skin cancer in the area to be treated.

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I have excessive facial hair that could affect treatment.

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I have a connective tissue disease like lupus or scleroderma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Degree of improvement

Secondary study objectives

Side effects

Subject satisfaction

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Port wine stainExperimental Treatment1 Intervention

The port wine stain will be treated with the DermaV laser. Within the single port wine stain, one area will be treated with standard settings (single pulse high fluence). Four other areas will be treated with multi-pulse low fluence settings. A sixth area will be an untreated control.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The 532 nm laser treatment for Port-Wine Stain (PWS) operates on the principle of selective photothermolysis, where a specific wavelength of light targets and heats the abnormal blood vessels in the skin. This targeted heating causes the blood vessels to coagulate and be reabsorbed by the body, thereby reducing the appearance of the stain. This mechanism is significant for PWS patients as it ensures that the treatment is precise, minimizing damage to surrounding tissues and leading to better cosmetic results with fewer side effects.

Can red-light 5-aminolevulinic photodynamic therapy cure port wine stains on comb animal model?