Clinical Trial: Combined Alexandrite and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Combined Alexandrite and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks

Brief Summary:

Port wine stain is a congenital, progressive vascular malformation of skin involving post-capillary venules that occurs in an estimated 4 children per 1,000 live births. Approximately 1,200,000 individuals in the United States and twenty-six million people worldwide have Port wine stain birthmarks.

Since most of the malformations occur on the face, Port wine stain is a clinically significant problem in the majority of patients. Port wine stain should not be considered a cosmetic problem but a disease with potentially devastating psychological and physical complications. Personality development is adversely influenced in virtually all patients by the negative reaction of others to a "marked" person. Port wine stain are initially flat red macules, but lesions tend to darken progressively to purple, and by middle age, often become raised as a result of the development of vascular nodules. Hypertrophy of underlying soft tissue further disfigures the facial features of many patients.


Detailed Summary: The researcher can use alexandrite and pulsed dye lasers pulses combined delivery to improve port wine stain blanching. The alexandrite and pulsed dye lasers are both approved by the Food and Drug Administration for the treatment of Port wine stain. However, the degree of port wine stain blanching seen following either alexandrite or pulsed dye lasers treatment remains variable and unpredictable. Treatment of port wine stains can use either alexandrite or pulsed dye alone and with the combined delivery of alexandrite and pulsed dye lasers pulses.
Sponsor: University of California, Irvine

Current Primary Outcome: Port Wine Stain Birthmarks blanching [ Time Frame: 8 weeks ]

Post-treatment blanching responses can determine quantitatively by visual reflectance spectroscopy and compare with pre-treatment measurements of Port Wine Stain fractional blood volume


Original Primary Outcome: Improvement in blanching for the combined ALEX+PDL therapy in comparison with ALEX alone is calculated for each subject as B(ALEX+PDL) - B(ALEX). [ Time Frame: 8 weeks ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of California, Irvine

Dates:
Date Received: December 18, 2007
Date Started: April 2007
Date Completion:
Last Updated: February 8, 2017
Last Verified: February 2017