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

This study has been terminated.
(Unable to solve the software problem that results in excessive skin cooling)
Sponsor:
Collaborators:
Beckman Laser Institute University of California Irvine
Candela Corporation
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00580944
First received: December 18, 2007
Last updated: October 28, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Port Wine Stain
Procedure: alexandrite laser and pulsed dye laser
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:
  • 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 ]

Enrollment: 0
Study Start Date: April 2007
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: laser treament
PWS birthmark
Procedure: alexandrite laser and pulsed dye laser
ALEX/PDL laser

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.

  Eligibility

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

Locations
United States, California
Beckman Laser institute medical and surgical clinic
Irvine, California, United States, 92612
Sponsors and Collaborators
Montana Compton
Beckman Laser Institute University of California Irvine
Candela Corporation
Investigators
Principal Investigator: JOHN S NELSON, M.D,Ph.D BECKMAN LASER INSTITUTE
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00580944     History of Changes
Other Study ID Numbers: NIH NIBIB;EB-02495-05
Study First Received: December 18, 2007
Last Updated: October 28, 2011
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
Skin Abnormalities
Congenital Abnormalities
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014