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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Port wine stain | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 532 nm laser treatment | Device | The port wine birthmark will be treated with the DermaV 532 nm laser. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of improvement | For each treatment area within the port wine stain, a blinded investigator will assess improvement (0 - 25%, 26 - 50%, 51 - 75%, 76 - 100%) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Subject satisfaction | For each treatment area within the port wine stain, subject will assess satisfaction on a 1-4 scale | 6 months |
| Side effects | subject and treating physician will assess side effects of treatment including pain, swelling, skin discoloration, scar |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cemre Turk, MD | Contact | 6175133337 | cturk@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Yakir Levin, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wellman Center for Photomedicine, Harvard Medical School | Recruiting | Boston | Massachusetts | 02114 | United States |
Individual participant data will not be shared for this pilot study.
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| ID | Term |
|---|---|
| D019339 | Port-Wine Stain |
| ID | Term |
|---|---|
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012871 | Skin Diseases |
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| 6 months |
| D017437 | Skin and Connective Tissue Diseases |