Measurement Skin Temperature During Pulsed Laser Exposure - Tabular View

Tracking Information

First Received Date ^ICMJE

October 4, 2007

Last Updated Date

March 12, 2009

Start Date ^ICMJE

July 2002

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00540917 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Measurement Skin Temperature During Pulsed Laser Exposure

Official Title ^ICMJE

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.

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.

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Port Wine Stain Birthmark

Intervention ^ICMJE

Procedure: cooling spray during laser treatment

Study Arms / Comparison Groups

Experimental: during laser treatment of portwine stain skin

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

July 2012

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

7 Years to 75 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00540917

Responsible Party

John S. Nelson, M.D., Ph.D, Beckman Laser Institute

Study ID Numbers ^ICMJE

CANDELAR can-44711, ASLMS-41746, LAMMP RR-01192-29

Study Sponsor ^ICMJE

University of California, Irvine

Collaborators ^ICMJE

Beckman Laser Institute University of California Irvine
Candela Corporation

Investigators ^ICMJE

Principal Investigator:

John S. Nelson, M.D., Ph.D

Beckman Laser Institute University of California Irvine

Information Provided By

University of California, Irvine

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP