Measurement Skin Temperature During Pulsed Laser Exposure

This study has been completed.
Sponsor:
Collaborators:
Beckman Laser Institute University of California Irvine
Candela Corporation
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00540917
First received: October 4, 2007
Last updated: June 9, 2015
Last verified: June 2015
  Purpose

Lasers are the treatment modality of choice for Port Wine Stain birthmarks.The epidermis is not totally spared due to partial absorption of energy therein by melanin that 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.


Condition Intervention Phase
Port-Wine Stain
Procedure: cooling spray during laser treatment
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial is to Compare Epidermal Temperature Measurements During 1.Laser Treatment at Standard Treatment Energies 2.Cryogen Spray Cooling (CSC) Plus Laser Treatment. 3.Contact Cooling Plus Laser Treatment.

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

Primary Outcome Measures:
  • skin temperature during laser treatment [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Enrollment: 118
Study Start Date: July 2002
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cooling spray
cooling spray during laser treatment
Procedure: cooling spray during laser treatment
skin temperature measurement
Other Name: laser treatment

Detailed Description:

The researchers want to establish a correlation between non-invasive skin temperature measurements and the minimum laser energy during skin laser treatment using cryogen spray cooling.

This study would eliminate the need for test pulses to estimate the safe and acceptable radiant exposure prior to laser treatment.

  Eligibility

Ages Eligible for Study:   7 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 7 years of age and older with diagnosis of port wine stain birthmark
  • 18 years of age and older with no port wine stain
  • non-pregnant women
  • apparent good health

Exclusion Criteria:

  • age less than 7 years old
  • pregnant women
  • history of photodermatoses or skin cancer
  • current use of photosensitizing drugs
  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: NCT00540917

Locations
United States, California
Beckman Laser Institute Medical Clinic University of California Irvine
Irvine, California, United States, 92612
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Candela Corporation
Investigators
Principal Investigator: John S. Nelson, M.D., Ph.D Beckman Laser Institute University of California Irvine
  More Information

No publications provided

Responsible Party: Beckman Laser Institute and Medical Center, J S Nelson, M.D., Ph.D.,Professor of Surgery and Biomedical Engineering, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00540917     History of Changes
Other Study ID Numbers: NIH-LAMMP-1999-2250
Study First Received: October 4, 2007
Last Updated: June 9, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 01, 2015