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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.
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00540371
First received: October 4, 2007
Last updated: February 8, 2017
Last verified: February 2017
  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 port wine stain 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 treatment.


Condition Intervention
Port Wine Stain Other: Port wine stain Birthmark

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

Resource links provided by NLM:


Further study details as provided by Beckman Laser Institute and Medical Center, 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)
Groups/Cohorts Assigned Interventions
Port wine stain Birthmark
Port wine stain Birthmark
Other: Port wine stain Birthmark
Port wine stain Birthmark

Detailed Description:

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

The flashlamp-pumped pulsed dye laser has become the treatment of choice for port wine stain 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 port wine stain birthmarks. This technology allows the use of higher incident laser light dosages and has been demonstrated to improve treatment results. cryogen spray cooling also decreases treatment pain and the duration of post-laser treatment purpura.

  Eligibility

Ages Eligible for Study:   1 Month to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Kristen Kelly, M.D Beckman Laser Institue University of California Irvine
  More Information

Responsible Party: Beckman Laser Institute and Medical Center, Kristen Kelly, M.D.,Professor Departments of Dermatology and Surgery, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00540371     History of Changes
Other Study ID Numbers: NIH-LAMMP-1999-2154
Study First Received: October 4, 2007
Last Updated: February 8, 2017

Keywords provided by Beckman Laser Institute and Medical Center, University of California, Irvine:
Port Wine Stain

Additional relevant MeSH terms:
Port-Wine Stain
Hemangioma, Capillary
Vascular Malformations
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Cardiovascular Abnormalities
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 26, 2017