search
Back to results

Combined Use of Pulsed Dye Laser and Topical Antiangiogenic Agents for Treatment of Port Wine Stain Birthmarks

Primary Purpose

Port Wine Stain

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Topical Antiangiogenic
Pulsed Dye Laser
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 Birthmark, PWS

Eligibility Criteria

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

Inclusion Criteria:

  • 16 years of age and older
  • Have PWS suitable for comparison testing as determined by the study doctor

Exclusion Criteria:

  • Less than 16 years old
  • Are pregnant
  • Have skin cancer
  • Currently taking immunosuppressive or steroids or photosensitizing drugs
  • Current participation in any other investigational drug evaluation
  • Concurrent use of known photosensitizing drugs

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Topical Antiangiogenic

    Pulsed Dye Laser

    Arm Description

    Topical Antiangiogenic Agents

    Pulsed Dye Laser

    Outcomes

    Primary Outcome Measures

    Improve PWS lesion blanching.

    Secondary Outcome Measures

    To determine whether the combined use of pulsed dye laser (PDL) therapy and topical agent will improve PWS outcome.

    Full Information

    First Posted
    August 31, 2009
    Last Updated
    October 28, 2022
    Sponsor
    University of California, Irvine
    Collaborators
    Beckman Laser Institute University of California Irvine
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00969397
    Brief Title
    Combined Use of Pulsed Dye Laser and Topical Antiangiogenic Agents for Treatment of Port Wine Stain Birthmarks
    Official Title
    Combined Use of Pulsed Dye Laser and Topical Antiangiogenic Agents for Treatment of Port Wine Stain Birthmarks
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    We have decided not to pursue the study
    Study Start Date
    November 2009 (undefined)
    Primary Completion Date
    September 2011 (Actual)
    Study Completion Date
    September 2011 (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
    Yes

    5. Study Description

    Brief Summary
    The researcher want to improve port wine stain (PWS) therapeutic outcome in response to laser therapy. The researcher want to determine whether the combined use of pulsed dye laser (PDL) therapy and topical tacrolimus or pimecrolimus will improve PWS therapeutic outcome.
    Detailed Description
    Both topical agents inhibit nuclear factor of activated T-cells (NFAT) which blocks the calcineurin/NFAT pathway inhibiting endothelial cell proliferation and angiogenesis, which could be very useful in preventing PWS recanalization. The combined use of PDL to induce PWS blood vessel injury, and topical antiangiogenic agents to prevent PWS blood vessel angiogenesis and recanalization after laser therapy, will improve PWS 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
    Birthmark, PWS

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Topical Antiangiogenic
    Arm Type
    Experimental
    Arm Description
    Topical Antiangiogenic Agents
    Arm Title
    Pulsed Dye Laser
    Arm Type
    Experimental
    Arm Description
    Pulsed Dye Laser
    Intervention Type
    Drug
    Intervention Name(s)
    Topical Antiangiogenic
    Intervention Description
    Topical Antiangiogenic
    Intervention Type
    Device
    Intervention Name(s)
    Pulsed Dye Laser
    Intervention Description
    Pulsed Dye Laser
    Primary Outcome Measure Information:
    Title
    Improve PWS lesion blanching.
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    To determine whether the combined use of pulsed dye laser (PDL) therapy and topical agent will improve PWS outcome.
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 16 years of age and older Have PWS suitable for comparison testing as determined by the study doctor Exclusion Criteria: Less than 16 years old Are pregnant Have skin cancer Currently taking immunosuppressive or steroids or photosensitizing drugs Current participation in any other investigational drug evaluation Concurrent use of known photosensitizing drugs
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Combined Use of Pulsed Dye Laser and Topical Antiangiogenic Agents for Treatment of Port Wine Stain Birthmarks

    We'll reach out to this number within 24 hrs