A Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks.

NCT00830466

Last updated date
Study Location
Beckman Laser Institute and Medical Clinic
Irvine, California, 92612, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Port Wine Stain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Port Wine StainA Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks.
NCT00800722
  1. Irvine, California
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Port Wine StainA Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks.
NCT00830466
  1. Irvine, California
ALL GENDERS
13 Years+
years
MULTIPLE SITES
Advanced Information
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 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
 (submitted: January 29, 2016)
22
Original Estimated Enrollment  ICMJE
 (submitted: January 27, 2009)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Plan to Share IPD:Undecided
Responsible Party Beckman Laser Institute and Medical Center, University of California, Irvine
Study Sponsor  ICMJE University of California, Irvine
Collaborators  ICMJE
  • Beckman Laser Institute University of California Irvine
  • Pfizer
Investigators  ICMJE
Principal Investigator:J. Stuart Nelson, M.D.,Ph.D.Beckman Laser Institute and Medical Clinic, 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