A Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks.
NCT00800722
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Adult Trials: 18+ Years
- port wine stain birthmarks suitable for comparison testing.
- 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.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks. | |||
| Official Title ICMJE | Phase I Combined Use of Pulsed Dye Laser and Rapamycin | |||
| Brief Summary | 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. | |||
| Detailed 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. | |||
| 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: Rapamycin Treatment of Port Wine Stain
Treatment of Port Wine Stain Other Name: Treatment of Port Wine Stain | |||
| Study Arms ICMJE | Experimental: Treatment of Port Wine Stain
Rapamycin Treatment of Port Wine Stain Intervention: Drug: Rapamycin Treatment of Port Wine Stain | |||
| 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 | 21 | |||
| Original Estimated Enrollment ICMJE | 25 | |||
| Actual Study Completion Date ICMJE | June 2014 | |||
| Actual Primary Completion Date | June 2014 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (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 | NCT00800722 | |||
| Other Study ID Numbers ICMJE | NIH/LAMMP6383 | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| 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 | ||||