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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial looks at how well laser treatment works for port wine birthmarks, comparing two different approaches.
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.Check my eligibility
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.See study design
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 belowSelect...
I have a port wine stain not on my face that covers at least 30cm2.
Select...
I won't have cosmetic treatments on the study areas during the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Degree of improvement
Secondary outcome measures
Side effects
Subject satisfaction
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.
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Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,935 Previous Clinical Trials
13,198,626 Total Patients Enrolled
2 Trials studying Port-Wine Stain
10 Patients Enrolled for Port-Wine Stain
Yakir Levin, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of unusual scarring or healing, or you bruise easily.You are very sensitive to light.People with any skin type can participate.I have a port wine stain not on my face that covers at least 30cm2.You have a history of skin color changes that the study doctor doesn't think is okay for this study.I am between 18 and 75 years old.I won't have cosmetic treatments on the study areas during the trial.I have a history of skin or blood vessel disorders.I have had herpes or shingles flare-ups from heat in the area to be treated, but can follow a preventive treatment plan.I have a serious health condition like diabetes, HIV/AIDS, or I am on immunosuppressive medication.I am willing and able to follow through with Lutronic DermaV treatments and care instructions.I haven't had cosmetic or port wine stain treatments in the last 3 months.I am willing to limit my sun exposure and use sunscreen daily during the study.I am not pregnant or breastfeeding and use birth control or am unable to have children.I do not have major skin issues like open wounds or severe rashes in the area to be treated.I am taking medication that makes my skin more sensitive to light.I have had skin cancer in the area to be treated.I have excessive facial hair that could affect treatment.You have recently tanned skin in the area to be treated, or you are not likely to avoid tanning during the study.I have a connective tissue disease like lupus or scleroderma.
Research Study Groups:
This trial has the following groups:- Group 1: Port wine stain
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals over 35 years of age eligible to enroll in this trial?
"This clinical trial is open to individuals aged 18-75. Additionally, there are 1 study and 4 studies respectively for people who are underaged or over the age of retirement."
Answered by AI
For which demographics is enrollment into this trial available?
"This medical trial requires individuals with port-wine stain and aged 18 to 75 for enrollment. As of now, 15 participants have been accepted into the study."
Answered by AI
Is there an opportunity for new participants to join this clinical experiment?
"As per clinicaltrials.gov, this medical study is no longer searching for participants; the trial was first publicized on May 1st 2023 and last amended on April 23rd of the same year. Despite that, there are 5 other studies presently in search of patients at this juncture."
Answered by AI
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