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Measurement Skin Temperature During Pulsed Laser Exposure

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ClinicalTrials.gov Identifier: NCT00540917
Recruitment Status : Completed
First Posted : October 8, 2007
Last Update Posted : February 10, 2017
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

Brief Summary:
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 or disease Intervention/treatment Phase
Port-Wine Stain Procedure: cooling spray during laser treatment Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : July 2002
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Arm Intervention/treatment
Experimental: cooling spray
cooling spray during laser treatment
Procedure: cooling spray during laser treatment
skin temperature measurement
Other Name: laser treatment



Primary Outcome Measures :
  1. skin temperature during laser treatment [ Time Frame: 90 days ]


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Ages Eligible for Study:   7 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 8, 2007    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017

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