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

University of California Irvine (UCI)

Status and phase

Completed

Phase 1

Conditions

Port Wine Stain

Treatments

Drug: Rapamycin Treatment of Port Wine Stain

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00800722

20086383.

Details and patient eligibility

About

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.

Full 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 vascular endothelial growth factor which preventing port wine stain angiogenesis and recanalization, to improve port wine stain lesion blanching.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.