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

This study is enrolling participants by invitation only.
Study NCT00580944.   Last updated on July 25, 2008.   Information provided by University of California, Irvine

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Descriptive Information Fields
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
Brief Summary

Port wine stain (PWS) 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 PWS birthmarks.

Since most of the malformations occur on the face, PWS is a clinically significant problem in the majority of patients. PWS 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. PWS 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' want to determine whether the combined delivery of ALEX+PDL pulses will improve PWS therapeutic outcome in response to laser therapy. The central hypothesis of the proposed research is that the combined delivery of both ALEX+PDL pulses, as compared to either alone will increase the core intravascular PWS blood vessel temperature because of significant heat accumulation in the vessels by successive laser pulses while multiple cryogen spurts will maintain the epidermal temperature well below the damage threshold.

Port wine stains (PWS) are a congenital, progressive vascular malformation of human skin. The alexandrite (ALEX) and pulsed dye lasers (PDL) are both approved by the Food and Drug Administration (FDA) for the treatment of PWS. However, the degree of PWS blanching seen following either ALEX or PDL treatment remains variable and unpredictable.

For each subject, areas of the PWS will be treated with either ALEX or PDL alone and with the combined delivery of ALEX+PDL pulses. We expect that the areas treated with the combined delivery of ALEX+PDL pulses will have improved PWS blanching responses than the areas treated with either ALEX or PDL alone.

Study Phase Phase I
Study Type  Interventional
Study Design  Treatment, Non-Randomized, Open Label, Single Group Assignment
Primary Outcome Measure  Improvement in blanching for the combined ALEX+PDL therapy in comparison with ALEX alone is calculated for each subject as B(ALEX+PDL) - B(ALEX). [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure 
Condition  Port Wine Stain
Intervention  Procedure: alexandrite laser and pulsed dye laser
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status  Enrolling by invitation
Enrollment  20
Start Date  April 2007
Completion Date July 2012
Eligibility Criteria 

Inclusion Criteria:

  • PWS 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 PWS treatment sites
  • Current participation in any other investigational drug or device evaluation
  • Concurrent use of known photosensitizing drugs
Gender Both
Ages 12 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00580944
Organization ID #RR-01192:PHS-NIH
Secondary IDs ††
Study Sponsor  University of California, Irvine
Collaborators †† Beckman Laser Institute Medical Clinic
Candela Corporation
Investigators 
Principal Investigator:     JOHN S NELSON, M.D,Ph.D     BECKMAN LASER INSTITUTE    
Information Provided By University of California, Irvine
Verification Date July 2008
First Received Date  December 18, 2007
Last Updated Date July 25, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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