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

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ClinicalTrials.gov Identifier: NCT00580944
Recruitment Status : Withdrawn (No participant enrolled)
First Posted : December 27, 2007
Last Update Posted : February 10, 2017
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine

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.


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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Alexandrite and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
Study Start Date : April 2007
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012


Arm Intervention/treatment
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




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



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 27, 2007    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017

Keywords provided by Beckman Laser Institute and Medical Center, University of California, Irvine:
Port wine stain
progressive malformation of human skin

Additional relevant MeSH terms:
Port-Wine Stain
Hemangioma, Capillary
Vascular Malformations
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Cardiovascular Abnormalities
Cardiovascular Diseases