A Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks.
Completed · Phase 1
Conditions studied: Port Wine Stain
In brief
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.
Key facts
- Study ID
- NCT00830466
- Run by
- University of California, Irvine
- People needed
- 22
- Starts
- 2008-12-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2022-11-01
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Beckman Laser Institute and Medical Clinic — Irvine, California, United States
Full record on ClinicalTrials.gov
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