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

This study has been completed.
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00540371
First received: October 4, 2007
Last updated: October 28, 2011
Last verified: October 2011
  Purpose

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.


Condition
Port Wine Stain

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Dynamic Epidermal Cooling During Pulsed Dye Laser Treatment of Port Wine Stain

Further study details as provided by University of California, Irvine:

Enrollment: 136
Study Start Date: December 1999
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   1 Month to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540371

Locations
United States, California
Beckman Lase Institute Medical Clinic Unversity of California Irvine
Irvine, California, United States, 92612
Sponsors and Collaborators
Montana Compton
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Kristen Kelly, M.D Beckman Laser Institue University of California Irvine
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00540371     History of Changes
Other Study ID Numbers: LAMMP
Study First Received: October 4, 2007
Last Updated: October 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Port Wine Stain

Additional relevant MeSH terms:
Port-Wine Stain
Skin Abnormalities
Congenital Abnormalities
Skin Diseases

ClinicalTrials.gov processed this record on September 30, 2014