Status:
COMPLETED
A Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks.
Lead Sponsor:
University of California, Irvine
Collaborating Sponsors:
Pfizer
Beckman Laser Institute University of California Irvine
Conditions:
Port Wine Stain
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to improve port wine stain therapeutic outcome in response to laser therapy. The researchers want to determine whether the combined use of pulsed dye laser therapy and rap...
Detailed Description
The researchers want to combined use of pulsed dye laser to induce port wine stain blood vessel injury, and rapamycin directly inhibits the proliferation of vascular endothelial cells driven by vascul...
Eligibility Criteria
Inclusion
- port wine stain birthmarks suitable for comparison testing.
Exclusion
- Pregnancy.
- Abnormal blood hematology or chemistry blood tests or urine analysis.
- History of cancer, History of high cholesterol, lipids or liver disease
- Allergy to macrolide drugs (e.g., erythromycin).
- Any therapy within the previous two months to the proposed PWS treatment sites.
- Concurrent use of known photosensitizing drugs,immunosuppressive drugs or systemic steroids,antifungals, antiepileptics, HIV protease inhibitors, cimetidine, cisapride, clarithromycin, dannzol, diltiazem, erythromycin, metoclopramide, rifabutin, rifampin, rifapentine, troleandomycin, or verapamil.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00800722
Start Date
November 1 2008
End Date
June 1 2014
Last Update
November 1 2022
Active Locations (1)
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1
Beckman Laser Institute Medical clinic
Irvine, California, United States, 92612