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

This study has been withdrawn prior to enrollment.
(No participant enrolled)
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00580944
First received: December 18, 2007
Last updated: August 5, 2015
Last verified: August 2015
  Purpose

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.


Condition Intervention Phase
Port Wine Stain
Procedure: laser treatment of port wine stain birthmarks
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Alexandrite and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Port Wine Stain Birthmarks blanching [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Post-treatment blanching responses can determine quantitatively by visual reflectance spectroscopy and compare with pre-treatment measurements of Port Wine Stain fractional blood volume


Enrollment: 0
Study Start Date: April 2007
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Port Wien Stain Birthmark
Combined alexandrite and pulsed dye laser treatment of port wine stain birthmarks
Procedure: laser treatment of port wine stain birthmarks
Combined alexandrite and pulsed dye laser treatment of port wine stain birthmarks

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00580944

Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: JOHN S NELSON, M.D,Ph.D Beckman Laser Institute
  More Information

No publications provided

Responsible Party: Beckman Laser Institute and Medical Center, J.S.Nelson, MD,PhD,Professor of Surgery and Biomedical Engineering, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00580944     History of Changes
Other Study ID Numbers: NIH-LAMMP-2006-4992
Study First Received: December 18, 2007
Last Updated: August 5, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Port wine stain
progressive malformation of human skin

Additional relevant MeSH terms:
Port-Wine Stain
Congenital Abnormalities
Skin Abnormalities
Skin Diseases

ClinicalTrials.gov processed this record on September 01, 2015