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A 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
Laser and rapamycin versus laser alone
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Port Wine Stain focused on measuring port wine stain

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beckman Laser Institute and Medical Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laser and rapamycin versus laser alone

Arm Description

Laser and rapamycin versus laser alone

Outcomes

Primary Outcome Measures

Improved port wine stain fading/blanching after laser treatment
Efficacy will be determined by objectively measuring and comparing the port wine stain fading/blanching responses for subjects treated with combined pulsed dye laser and rapamycin versus pulsed dye laser alone

Secondary Outcome Measures

Full Information

First Posted
January 27, 2009
Last Updated
October 28, 2022
Sponsor
University of California, Irvine
Collaborators
Beckman Laser Institute University of California Irvine, Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00830466
Brief Title
A Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks.
Official Title
A Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
Beckman Laser Institute University of California Irvine, Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Port Wine Stain
Keywords
port wine stain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser and rapamycin versus laser alone
Arm Type
Experimental
Arm Description
Laser and rapamycin versus laser alone
Intervention Type
Drug
Intervention Name(s)
Laser and rapamycin versus laser alone
Intervention Description
Laser and rapamycin versus laser alone
Primary Outcome Measure Information:
Title
Improved port wine stain fading/blanching after laser treatment
Description
Efficacy will be determined by objectively measuring and comparing the port wine stain fading/blanching responses for subjects treated with combined pulsed dye laser and rapamycin versus pulsed dye laser alone
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Stuart Nelson, M.D.,Ph.D.
Organizational Affiliation
Beckman Laser Institute and Medical Clinic, University of California Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beckman Laser Institute and Medical Clinic
City
Irvine
State/Province
California
ZIP/Postal Code
92612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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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