New laser study aims to make port wine stain treatment more comfortable
NCT ID NCT05841628
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how well people tolerate laser treatment for port wine birthmarks using an FDA-approved 532 nm laser. Fifteen adults with non-facial birthmarks will receive three monthly treatments, comparing the standard single high-energy pulse to multiple low-energy pulses. The goal is to see which approach causes less discomfort and gives better results.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
Locations
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Wellman Center for Photomedicine, Harvard Medical School
RECRUITINGBoston, Massachusetts, 02114, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.