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Dynamic Epidermal Cooling During Pulsed Dye Laser Treatment of Port Wine Stain Birthmark at High Fluences
This study has been completed.
Study NCT00540371   Information provided by University of California, Irvine
First Received: October 4, 2007   Last Updated: March 13, 2009   History of Changes

October 4, 2007
March 13, 2009
December 1999
February 2009   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00540371 on ClinicalTrials.gov Archive Site
 
 
 
Dynamic Epidermal Cooling During Pulsed Dye Laser Treatment of Port Wine Stain Birthmark at High Fluences
Dynamic Epidermal Cooling During Pulsed Dye Laser Treatment of Port Wine Stain

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.

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.

 
Observational
Case-Only, Retrospective
Port Wine Stain
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
136
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
1 Month to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00540371
Kristen Kelly, MD, Beckman Laser Institute
LAMMP
University of California, Irvine
Beckman Laser Institute University of California Irvine
Principal Investigator: Kristen Kelly, M.D Beckman Laser Institue University of California Irvine
University of California, Irvine
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP