search
Back to results

Combined Alexandrite and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks

Primary Purpose

Port Wine Stain

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
laser treatment of port wine stain birthmarks
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, progressive malformation of human skin

Eligibility Criteria

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

Inclusion Criteria:

  • Port Wine Stain suitable for comparison testing
  • Age > 12 years and older
  • minor will be accompanied by parents or guardians during laser treatment
  • Apparent good health as documented by medical history

Exclusion Criteria:

  • History of photodermatoses or skin cancer
  • Any therapy within the previous two months to the proposed Port Wine Stain treatment sites
  • Current participation in any other investigational drug or device evaluation
  • Concurrent use of known photosensitizing drugs

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Port Wien Stain Birthmark

    Arm Description

    Combined alexandrite and pulsed dye laser treatment of port wine stain birthmarks

    Outcomes

    Primary Outcome Measures

    Port Wine Stain Birthmarks blanching
    Post-treatment blanching responses can determine quantitatively by visual reflectance spectroscopy and compare with pre-treatment measurements of Port Wine Stain fractional blood volume

    Secondary Outcome Measures

    Full Information

    First Posted
    December 18, 2007
    Last Updated
    October 19, 2022
    Sponsor
    University of California, Irvine
    Collaborators
    Beckman Laser Institute University of California Irvine
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00580944
    Brief Title
    Combined Alexandrite and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
    Official Title
    Combined Alexandrite and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No participant enrolled
    Study Start Date
    April 2007 (undefined)
    Primary Completion Date
    July 2012 (Actual)
    Study Completion Date
    July 2012 (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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Port wine stain is a congenital, progressive vascular malformation of skin involving post-capillary venules that occurs in an estimated 4 children per 1,000 live births. Approximately 1,200,000 individuals in the United States and twenty-six million people worldwide have Port wine stain birthmarks. Since most of the malformations occur on the face, Port wine stain is a clinically significant problem in the majority of patients. Port wine stain should not be considered a cosmetic problem but a disease with potentially devastating psychological and physical complications. Personality development is adversely influenced in virtually all patients by the negative reaction of others to a "marked" person. Port wine stain are initially flat red macules, but lesions tend to darken progressively to purple, and by middle age, often become raised as a result of the development of vascular nodules. Hypertrophy of underlying soft tissue further disfigures the facial features of many patients.
    Detailed Description
    The researcher can use alexandrite and pulsed dye lasers pulses combined delivery to improve port wine stain blanching. The alexandrite and pulsed dye lasers are both approved by the Food and Drug Administration for the treatment of Port wine stain. However, the degree of port wine stain blanching seen following either alexandrite or pulsed dye lasers treatment remains variable and unpredictable. Treatment of port wine stains can use either alexandrite or pulsed dye alone and with the combined delivery of alexandrite and pulsed dye lasers pulses.

    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, progressive malformation of human skin

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Port Wien Stain Birthmark
    Arm Type
    Experimental
    Arm Description
    Combined alexandrite and pulsed dye laser treatment of port wine stain birthmarks
    Intervention Type
    Procedure
    Intervention Name(s)
    laser treatment of port wine stain birthmarks
    Intervention Description
    Combined alexandrite and pulsed dye laser treatment of port wine stain birthmarks
    Primary Outcome Measure Information:
    Title
    Port Wine Stain Birthmarks blanching
    Description
    Post-treatment blanching responses can determine quantitatively by visual reflectance spectroscopy and compare with pre-treatment measurements of Port Wine Stain fractional blood volume
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Port Wine Stain suitable for comparison testing Age > 12 years and older minor will be accompanied by parents or guardians during laser treatment Apparent good health as documented by medical history Exclusion Criteria: History of photodermatoses or skin cancer Any therapy within the previous two months to the proposed Port Wine Stain treatment sites Current participation in any other investigational drug or device evaluation Concurrent use of known photosensitizing drugs
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    JOHN S NELSON, M.D,Ph.D
    Organizational Affiliation
    Beckman Laser Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Combined Alexandrite and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks

    We'll reach out to this number within 24 hrs