A Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain … (NCT00830466) | Clinical Trial Compass
CompletedPhase 1
A Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks.
United States22 participantsStarted 2008-12
Plain-language 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.
Who can participate
Age range13 Years
SexALL
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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.
What they're measuring
1
Improved port wine stain fading/blanching after laser treatment