A Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks.

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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 rapamycin will improve PWS therapeutic outcome.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Irvine
• Collaborators: Beckman Laser Institute University of California Irvine; Pfizer
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• port wine stain birthmarks suitable for comparison testing.

Exclusion Criteria:

• 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.