Laser Treatment for Port-Wine Stains
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are using medications that increase sensitivity to light, you may need to stop them according to the investigator's discretion.
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Follow-up
Participants are monitored for safety, effectiveness, and side effects after treatment
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?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Citations
[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 stains
Notes: The capillary malformation is shown before treatment (A) and after one session of 532 nm potassium titanyl phosphate laser treatment (B).
5.
clinicaltrials.gov
clinicaltrials.gov/study/NCT05771311?term=AREA%5BConditionSearch%5D(%22Hemangioma,%20Capillary%22)&rank=8KTP Laser vs Pulsed Dye Laser for Port-Wine Stains
Nevus 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-Analyses
The objective of this systematic review was to review the effectiveness and safety of recognized therapies for untreated capillary malformations ...
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