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The purpose of this study is to evaluate the efficacy and safety of the Matrix RF for Port Wine Stains based on clinical and histological analyses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Matrix RF followed by Pulse Dye Laser | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Matrix RF | Device | Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to complete healing | Assess safety of the Matrix RF treatment for port wine stains | Up to 30 weeks |
| Adverse events recording and monitoring | Up to 40 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clearance of port wine stain | Up to 40 weeks | |
| Lightening of the port wine stain | Evaluation of lightening of the port wine stain will be made with reflectance spectrophotometer at all treatments and at 6 and 12 weeks following the last treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser and Skin Surgery Center of New York | New York | New York | 10016 | United States |
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| ID | Term |
|---|---|
| D018324 | Hemangioma, Capillary |
| ID | Term |
|---|---|
| D006391 | Hemangioma |
| D009383 | Neoplasms, Vascular Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Matrix RF followed by Pulse Dye Laser | Device | Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week) |
|
| Pulse Dye Laser followed by Matrix RF | Device | Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week) |
|
| Up to 40 weeks |
| Improvement of port wine stain | Assessment to be done by the subject via subject questionnaire during these visits | Up to 30 weeks |
| Reduction in blood vessel concentration | Biopsies taken from consenting subjects at one of the time points will be analyzed | Up to 40 weeks |