Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
The purpose of this study is to improve port wine stain (PWS) therapeutic outcome in response to laser therapy. The researcher want to determine whether the combined use of pulsed dye laser (PDL) therapy and topical ranibizumab will improve PWS therapeutic outcome.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks|
- determine whether the combined use of PDL and topical ranibizumab will improve PWS therapeutic outcome [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2008|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: combined laser and ranibizumab treatment
port wine stain birthmarks
combined PDL laser and ranibizumab treatment
Combined use of PDL to induce PWS blood vessel injury, and ranibizumab to prevent PWS blood vessel angiogenesis and recanalization after laser therapy, will improve PWS lesion blanching.
Ranibizumab is a recombinant humanized monoclonal antibody fragment that works by attaching to and inhibiting the action of VEGF thereby preventing the growth and maintenance of blood vessels, which could be very useful in preventing PWS angiogenesis and recanalization.
After PDL treatment of the entire PWS, topical ranibizumab will be applied to two of the test sites for two weeks following PDL therapy. The degree of PWS blanching which will be quantified objectively using visible reflectance spectroscopy (VRS) measurements. PWS test site blanching responses following the combined use of PDL and topical ranibizumab will be compared with PDL only and with the baseline controls.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00667472
|Principal Investigator:||John s Nelson, M.D,PhD||Beckman Laser Institute University of California Irvine|