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

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The researchers want to collect data on safety and efficacy of combined pulsed dye laser and rapamycin to improve fading/blanching of port wine stain birthmarks as compared to pulsed dye laser alone, which is the current standard of care.

This single center pilot and feasibility study will have a target enrollment of 40 port wine stain subjects at the Beckman Laser Institute and Medical Clinic, University of California, Irvine.

• 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 suitable for comparison testing.

• Age > 13 years of age or older; minor will be accompanied in the room by parents or guardians during laser treatment.

• Apparent good health as documented by medical history.

• Ability to understand and carry out subject instructions.

• Women of childbearing potential must have a negative urinary pregnancy test prior to being started on rapamycin.

• Women of child bearing potential must agree to use a medically acceptable method of contraception throughout the study and for 3 months following discontinuation of rapamycin.

Exclusion Criteria:

• Inability to understand and carry out instructions.

• Pregnancy.

• Abnormal blood or urine tests

• 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 port wine stain treatment sites.

• Current participation in any other investigational drug evaluation.

• Concurrent use of known photosensitizing drugs.

• Concurrent use of immunosuppressive drugs or steroids.

• Concurrent use of any of the following medications: antifungals, antiepileptics, protease inhibitors, cimetidine, cisapride, clarithromycin, dannzol, diltiazem, erythromycin, metoclopramide, rifabutin, rifampin, rifapetine, troleandomycin, or verapamil.