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

Port Wine Stains Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00573729
• Other study ID #: 20065401
• Status: Completed
• Phase: Phase 1
• Start date: March 2007
• Est. completion date: January 2009

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Hemangioma, Capillary
• Port Wine Stains
• Port-Wine Stain

Intervention

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

Locations

Country	Name	City	State
United States	Beckman Laser Institute,University of California,Irvine	Irvine	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Beckman Laser Institute University of California Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in blanching for the 577 nm Pulsed Dye Laser therapy in comparison with 595 nm		8 weeks