Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks: Comparison of 577 nm Versus 595 nm Wavelengths
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Improvement in blanching for the 577 nm Pulsed Dye Laser therapy in comparison with 595 nm
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Months to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Pulsed Dye Laser 577 nm
Pulsed Dye Laser Treatment 577 nm treatment of Port Wine Stain Birthmarks
Intervention: Pulsed Dye Laser 577 nm (Other)
Pulsed Dye Laser 595 nm
Pulsed Dye Laser Treatment 595 nm treatment of Port Wine Stain Birthmarks
Intervention: Pulsed Dye Laser 595 nm (Other)
Outcomes
Primary Outcomes
Improvement in blanching for the 577 nm Pulsed Dye Laser therapy in comparison with 595 nm
Time Frame: 8 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Beckman Laser Institute and Medical Center
J.S.Nelson, MD,PhD,Professor of Surgery and Biomedical Engineering
University of California, Irvine