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:
Beckman Laser Institute University of California Irvine
Pfizer
Conditions:
Port Wine Stain
Eligibility:
All Genders
13+ years
Phase:
PHASE1
Brief 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, ...
Detailed Description
The study will offer two different approaches to the treatment of port wine stain birthmarks. Study Group Number 1: Port wine stain treated by the pulsed dye laser alone, which is the current standar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00830466
Start Date
December 1 2008
End Date
January 1 2016
Last Update
November 1 2022
Active Locations (1)
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1
Beckman Laser Institute and Medical Clinic
Irvine, California, United States, 92612