A Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks.
NCT00830466
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- 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.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | A Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks. | |||
Official Title ICMJE | A Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks. | |||
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, 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. | |||
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 standard of care: 20 subjects. Study Group Number 2: Port wine stain treated by combined pulsed dye laser and rapamycin: 20 subjects. 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. Twenty subjects will have their entire port wine stain birthmark treated by pulsed dye laser alone. Twenty subjects will have their entire port wine stain birthmark treated by combined pulsed dye laser and rapamycin, which is a drug that prevents the formation of blood vessels in the skin. Safety will be evaluated by searching for any local effects such as injury to the skin or systemic effects such as abnormal blood and/or urine studies. Efficacy will be determined by objectively measuring and comparing the port wine stain fading/blanching responses for the two study groups. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Port Wine Stain | |||
Intervention ICMJE | Drug: Laser and rapamycin versus laser alone
Laser and rapamycin versus laser alone | |||
Study Arms ICMJE | Experimental: Laser and rapamycin versus laser alone
Laser and rapamycin versus laser alone Intervention: Drug: Laser and rapamycin versus laser alone | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 22 | |||
Original Estimated Enrollment ICMJE | 25 | |||
Actual Study Completion Date ICMJE | January 2016 | |||
Actual Primary Completion Date | January 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 13 Years and older (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00830466 | |||
Other Study ID Numbers ICMJE | NIH/LAMMP-2008-6383 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Responsible Party | Beckman Laser Institute and Medical Center, University of California, Irvine | |||
Study Sponsor ICMJE | University of California, Irvine | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of California, Irvine | |||
Verification Date | February 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |