Combined Use of Pulsed Dye Laser and Topical Antiangiogenic Agents for Treatment of Port Wine Stain Birthmarks
The researcher want 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 tacrolimus or pimecrolimus will improve PWS therapeutic outcome.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||phase1/2 Combine PDL/Topical Agent for Treatment of PWS|
- Improve PWS lesion blanching. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- To determine whether the combined use of pulsed dye laser (PDL) therapy and topical agent will improve PWS outcome. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2009|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Experimental: combined PDL and topical agent
Other: combined PDL nad Topical Agent
Other Name: Protopic/Elidel
Both topical agents inhibit nuclear factor of activated T-cells (NFAT) which blocks the calcineurin/NFAT pathway inhibiting endothelial cell proliferation and angiogenesis, which could be very useful in preventing PWS recanalization.
The combined use of PDL to induce PWS blood vessel injury, and topical antiangiogenic agents to prevent PWS blood vessel angiogenesis and recanalization after laser therapy, will improve PWS lesion blanching.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969397
|United States, California|
|Beckman Laser Institute Medical clinic|
|Irvine, California, United States, 92612|
|Principal Investigator:||John S Nelson, M.D,PhD||Beckman Laser Institute University of California Irvine|