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Dynamic Epidermal Cooling During Pulsed Dye Laser Treatment of Port Wine Stain Birthmark at High Fluences

This study is enrolling participants by invitation only.
Information provided by University of California, Irvine

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Descriptive Information Fields
Brief Title  Dynamic Epidermal Cooling During Pulsed Dye Laser Treatment of Port Wine Stain Birthmark at High Fluences
Official Title  Dynamic Epidermal Cooling During Pulsed Dye Laser Treatment of Port Wine Stain
Brief Summary

The purpose of the study is to improve the efficacy of pulsed dye laser treatment of port wine stain birthmarks. Involvement in the protocol will involve formal documentation of the level of treatment pain, duration of post-treatment purpura and incidence of side effects. In addition, measurements will be taken of blood substances that promote blood vessel formation/regrowth and non-invasive reflectance measurements and photographs will be taken before and after treatment.

The objective of this study is to document the degree of PWS lightening, the incidence of side effects and the presence of angiogenic factors induced during treatment with the pulsed dye laser in association with cooling agent. This information ultimately lead to improved port wine stain treatment.

Detailed Description

The flashlamp-pumped pulsed dye laser (FLPDL) has offered the best results with the lowest incidence of side effects. The yellow light produced by the FLPDL is preferentially absorbed by hemoglobin allowing more selective destruction of the ectatic capillaries in the dermis.

FLPDL has become the treatment of choice for PWS birthmarks; however, therapeutic challenges remain. The epidermis is not totally spared due to partial absorption of energy therein by melanin which presents an optical barrier through which the light must pass to reach the underlying blood vessels. Absorption of laser energy by melanin causes localized heating in the epidermis, which may, if not controlled, produce permanent complications such as hypertrophic scarring or dyspigmentation.

Clinical studies have demonstrated the efficacy and safety of cryogen spray cooling during pulsed laser treatment of PWS birthmarks. This technology allows the use of higher incident laser light dosages and has been demonstrated to improve treatment results. CSC also decreases treatment pain and the duration of post-laser treatment purpura.

Currently, Candela's (Wayland, MA) ScleroPLUS provides CSC in combination with a tunable dye laser offering wavelengths. This laser is FDA approved and is currently being utilized for treatment of PWS birthmarks at the Beckman Laser Institute and many other laser clinics across the country.

Study Phase
Study Type  Observational
Study Design  Case-Only, Retrospective
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Port Wine Stain
Intervention 
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Enrolling by invitation
Enrollment  200
Start Date  December 1999
Completion Date July 2012
Eligibility Criteria 

Inclusion Criteria:

  • Diagnosis of PWS birthmark or age and sex matched control of a subject with a PWS birthmark
  • Apparent good health as documented by medical history and physical examination
  • Ability to understand and carry out subject instructions

Exclusion Criteria:

  • Pregnancy
  • History of cutaneous photosensitivity
  • History of photodermatoses, skin cancer or other cancer
  • Any therapy to the proposed treatment sites within the previous two months
  • Current participation in any other investigational drug evaluation
  • Concurrent use of known photosensitizing drugs
  • Inability to understand and carry out subject instructions
Gender Both
Ages 1 Month to 75 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00540371
Organization ID GM-62177,AR-47551,EB-02495
Secondary IDs †† AR-47551, UTA02-001, P41-RR01192;NIH-LAMMP
Study Sponsor  University of California, Irvine
Collaborators †† Beckman Laser Institute Medical Clinic
Investigators 
Principal Investigator:     Kristen Kelly, M.D     Beckman Laser Institue University of California Irvine    
Information Provided By University of California, Irvine
Verification Date May 2008
First Received Date  October 4, 2007
Last Updated Date May 22, 2008

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




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