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

CompletedPhase 1

Sponsor: University of California, Irvine

Conditions: Port Wine Stain

Interventions: Laser and rapamycin versus laser alone

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 13 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (1)

Irvine, California, United States