Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks: Comparison of 577 nm Versus 595 nm Wavelengths

Study Overview
=================
Brief Summary
-----------------
Port wine stain are a congenital, progressive vascular malformation of human skin. The pulsed dye laser is approved by the Food and Drug Administration for the treatment of choice. However, the degree of port wine stain blanching seen following pulsed dye laser treatment remains variable and unpredictable. If the ultimate standard required is complete lesion blanching, the average success rate is below 10%, even after undergoing numerous pulsed dye laser treatments. Moreover, less than 50% of patients achieve 50% fading of their Port wine stain in response to pulsed dye laser therapy.

Detailed Description
-----------------
The researchers' specific aim is to determine whether the use of the pulsed dye laser operating at a wavelength of 577 nm will improve therapeutic outcome as compared to a pulsed dye laser operating at 595 nm. The researcher can treat port wine stain treated using a pulsed dye laser operating at a wavelength of 577 nm and the other half at a wavelength of 595 nm. The researcher can determine that the 577 nm pulsed dye laser improved port wine stain blanching responses more than the areas treated with 595 nm. The degree of port wine stain blanching which will determine by visible reflectance spectroscopy skin imaging device measurements. Post-treatment blanching responses can compare with pre-treatment measurements of port wine stain fractional blood volume.

Official Title
-----------------
Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks: Comparison of 577 nm Versus 595 nm Wavelengths

Conditions
-----------------
Port Wine Stains

Intervention / Treatment
-----------------
* Other: Pulsed Dye Laser 577 nm
* Other: Pulsed Dye Laser 595 nm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Port Wine Stain suitable for comparison testing Age > 6 months of age; minor will be accompanied in the room by parents or guardians during laser treatment Apparent good health as documented by medical history Ability to understand and carry out subject instructions Exclusion Criteria: History of photodermatoses or skin cancer Any therapy within the previous two months to the proposed Port Wine Stain treatment sites Inability to understand and carry out instructions

Ages Eligible for Study
-----------------
Minimum Age: 6 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulsed Dye Laser 577 nm<br>Pulsed Dye Laser Treatment 577 nm treatment of Port Wine Stain Birthmarks | Other: Pulsed Dye Laser 577 nm<br>* Comparison of 577 nm Versus 595 nm Wavelengths of Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks<br>* Other names: Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks;|
| Experimental: Pulsed Dye Laser 595 nm<br>Pulsed Dye Laser Treatment 595 nm treatment of Port Wine Stain Birthmarks | Other: Pulsed Dye Laser 595 nm<br>* Comparison of 577 nm Versus 595 nm Wavelengths of Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks<br>* Other names: Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in blanching for the 577 nm Pulsed Dye Laser therapy in comparison with 595 nm |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vascular malformation