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Trial record 1 of 1 for:    NCT00800722
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A Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks.

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ClinicalTrials.gov Identifier: NCT00800722
Recruitment Status : Completed
First Posted : December 2, 2008
Last Update Posted : February 10, 2017
Sponsor:
Collaborators:
Pfizer
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine

Tracking Information
First Submitted Date  ICMJE December 1, 2008
First Posted Date  ICMJE December 2, 2008
Last Update Posted Date February 10, 2017
Study Start Date  ICMJE November 2008
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2008)
improve port wine stain (PWS) therapeutic outcome [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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
 (submitted: June 26, 2014)
21
Original Estimated Enrollment  ICMJE
 (submitted: December 1, 2008)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
  • Pfizer
  • Beckman Laser Institute University of California Irvine
Investigators  ICMJE
Principal Investigator: John S Nelson, M.D,PhD Beckman Laser Institute University of California Irvine
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