Measurement Skin Temperature During Pulsed Laser Exposure

This study is enrolling participants by invitation only.

First Received: October 4, 2007 Last Updated: March 12, 2009 History of Changes

Sponsor:	University of California, Irvine
Collaborators:	Beckman Laser Institute University of California Irvine Candela Corporation
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00540917

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 Birthmark	Procedure: cooling spray during laser treatment	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
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 ]

Estimated Enrollment:	300
Study Start Date:	July 2002
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
cooling spray: Experimental during laser treatment of portwine stain skin	Procedure: cooling spray during laser treatment skin temperature measurement

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

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 ( John S. Nelson, M.D., Ph.D )
Study ID Numbers:	CANDELAR can-44711, ASLMS-41746, LAMMP RR-01192-29
Study First Received:	October 4, 2007
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00540917 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

Port Wine Stain Birthmark

Additional relevant MeSH terms:

Skin Diseases
Port-Wine Stain
Skin Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on November 20, 2009