Treatment of port wine birthmarks with a laser

Tolerability of 532 nm Laser Treatment of Port Wine Stains

This study is testing a laser treatment for port wine birthmarks to see which method works better and is easier for patients to handle.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT05841628 on ClinicalTrials.gov

What this trial studies

This study evaluates the tolerability of an FDA-approved 532 nm laser treatment for port wine stains. Participants will receive three monthly treatments, with some areas treated using a standard single high fluence pulse and others with multiple low fluence pulses. The study aims to compare the tolerability and effectiveness of these two approaches in treating the birthmarks.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with non-facial port wine stains covering at least 30 cm².

Not a fit: Patients with facial port wine stains or those who cannot adhere to treatment protocols may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more tolerable and effective option for patients with port wine stains.

How similar studies have performed: Previous studies have shown promise in laser treatments for port wine stains, but this specific comparison of treatment approaches is novel.

Eligibility criteria

Inclusion 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.,

Exclusion Criteria:

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.

Where this trial is running

Boston, Massachusetts

• Wellman Center for Photomedicine, Harvard Medical School — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Yakir Levin, MD, PhD — Massachusetts General Hospital
• Study coordinator: Cemre Turk, MD

Conditions Port-Wine Stain