Back to resultsA Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks.
Primary Purpose
Port Wine Stain
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Rapamycin Treatment of Port Wine Stain
Sponsored by
About this trial
This is an interventional treatment trial for Port Wine Stain focused on measuring hypervascular anomalies
Eligibility Criteria
Inclusion Criteria:
- port wine stain birthmarks suitable for comparison testing.
Exclusion Criteria:
- 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.
Sites / Locations
- Beckman Laser Institute Medical clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment of Port Wine Stain
Arm Description
Rapamycin Treatment of Port Wine Stain
Outcomes
Primary Outcome Measures
improve port wine stain (PWS) therapeutic outcome
Secondary Outcome Measures
Full Information
NCT ID
NCT00800722
First Posted
December 1, 2008
Last Updated
October 28, 2022
Sponsor
University of California, Irvine
Collaborators
Pfizer, Beckman Laser Institute University of California Irvine
1. Study Identification
Unique Protocol Identification Number
NCT00800722
Brief Title
A Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks.
Official Title
Phase I Combined Use of Pulsed Dye Laser and Rapamycin
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
Pfizer, Beckman Laser Institute University of California Irvine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Port Wine Stain
Keywords
hypervascular anomalies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment of Port Wine Stain
Arm Type
Experimental
Arm Description
Rapamycin Treatment of Port Wine Stain
Intervention Type
Drug
Intervention Name(s)
Rapamycin Treatment of Port Wine Stain
Other Intervention Name(s)
Treatment of Port Wine Stain
Intervention Description
Treatment of Port Wine Stain
Primary Outcome Measure Information:
Title
improve port wine stain (PWS) therapeutic outcome
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
port wine stain birthmarks suitable for comparison testing.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John S Nelson, M.D,PhD
Organizational Affiliation
Beckman Laser Institute University of California Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beckman Laser Institute Medical clinic
City
Irvine
State/Province
California
ZIP/Postal Code
92612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks.
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