RECRUITING

Tolerability of 532 nm Laser Treatment of Port Wine Stains

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Tolerability of 532 nm Laser Treatment of Port Wine Stains

Quick Facts

Study Start:2023-05-01

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05841628

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. .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. 6. Willing to have very limited sun exposure and use sunscreen on the treatment area every day for the duration of the study, including the follow-up period. 7. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation (educational and/or marketing), publications, and any additional marketing purposes. 8. 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. 9. For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study.,	1. 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. 2. Any type of prior cosmetic or port wine stain treatment to the target area within 3 months of study participation. 3. 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). 4. Pregnant and/or breastfeeding, or planning to become pregnant. 5. Significant concurrent illness, such as diabetes mellitus, immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or using immunosuppressive medication. 6. Hypersensitivity to light exposure. 7. Any use of medication that is known to increase sensitivity to light according to the Investigator's discretion. 8. History of keloid scarring, hypertrophic scarring or abnormal wound healing or prone to bruising. 9. Has a history of squamous cell carcinoma or melanoma in the treatment area. 10. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders. 11. A history or active skin condition that in the opinion of the Investigator may interfere/confound with the treatment. 12. History of connective tissue disease, such as systemic lupus erythematosus or scleroderma. 13. History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen. 14. History of pigmentary disorders, particularly tendency for hyper- or hypo- pigmentation, or any that are considered not acceptable by the study investigator. 15. Excessively tanned or active sun tan in area to be treated, or unable/unlikely to refrain from tanning during the study. 16. Excessive hair in the area to be treated (beards, sideburns, and/or moustache,) that would interfere with diagnosis, assessment, and treatment. 17. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study, including excessive alcohol or drug abuses, or a condition that would compromise the subject's ability to comply with the study requirements.

Inclusion Criteria

Exclusion Criteria

1. .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.
6. Willing to have very limited sun exposure and use sunscreen on the treatment area every day for the duration of the study, including the follow-up period.
7. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation (educational and/or marketing), publications, and any additional marketing purposes.
8. 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.
9. For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study.,

1. 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.
2. Any type of prior cosmetic or port wine stain treatment to the target area within 3 months of study participation.
3. 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).
4. Pregnant and/or breastfeeding, or planning to become pregnant.
5. Significant concurrent illness, such as diabetes mellitus, immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or using immunosuppressive medication.
6. Hypersensitivity to light exposure.
7. Any use of medication that is known to increase sensitivity to light according to the Investigator's discretion.
8. History of keloid scarring, hypertrophic scarring or abnormal wound healing or prone to bruising.
9. Has a history of squamous cell carcinoma or melanoma in the treatment area.
10. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders.
11. A history or active skin condition that in the opinion of the Investigator may interfere/confound with the treatment.
12. History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
13. History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
14. History of pigmentary disorders, particularly tendency for hyper- or hypo- pigmentation, or any that are considered not acceptable by the study investigator.
15. Excessively tanned or active sun tan in area to be treated, or unable/unlikely to refrain from tanning during the study.
16. Excessive hair in the area to be treated (beards, sideburns, and/or moustache,) that would interfere with diagnosis, assessment, and treatment.
17. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study, including excessive alcohol or drug abuses, or a condition that would compromise the subject's ability to comply with the study requirements.

Contacts and Locations

Study Contact

Cemre Turk, MD

CONTACT

6175133337

cturk@mgh.harvard.edu

Principal Investigator

Yakir Levin, MD, PhD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Wellman Center for Photomedicine, Harvard Medical School

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Yakir Levin, MD, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-01

Study Completion Date2024-12

Study Record Updates

Study Start Date2023-05-01

Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

Port-Wine Stain