Measurement Skin TemperatureDuring Pulsed Laser Exposure - Full Text View

Purpose

PURPOSE OF STUDY

During laser treatment of port wine stain skin, some light is converted to heat in the top part of the skin as opposed to the deeper port wine stain birthmark. The purpose of this study is to make temperature measurements of the skin during laser treatment to determine how much light is converted to heat in the top part of the skin as opposed to the deeper port wine stain birthmark. The flash lamp pumped pulsed dye laser (FLPDL) and Alexandrite laser are the FDA approved treatments of choice for PWS.

The conversion of light to heat in the top part of the skin can lead to permanent scarring or changes in the normal color or pigmentation of the skin. A possible way to avoid these complications of laser therapy is to cool the top part of the skin by the application of a cooling agent. Therefore, skin temperature measurements will also be made while a cooling agent is applied to the skin surface immediately before or during laser treatment.

Condition	Intervention
Port Wine Stain Birthmark	Device: Optical properties mesurement

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective

Official Title:	Measurement Skin Temperature During Pulsed Laser Exposure

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

Biospecimen Retention: None Retained

Biospecimen Description:

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)

Groups/Cohorts	Assigned Interventions
1	Device: Optical properties mesurement skin temperature measurement

Detailed Description:

Procedure;

The study is to compare epidermal temperature measurements in PWS skin during: a) laser treatment at standard treatment energies (5-7 J/cm2); b) CSC plus laser treatment; and c) contact cooling plus laser treatment; d) make temperature measurements on normal human skin with and without cryogen spray cooling.

Port Wine Stain sites will be treated with the flash lamp pumped pulsed dye laser (FLPDL) or flash lamp excited long-pulse alexandrite laser (755 mm wavelength) without skin cooling at standard treatment fluences of 5-7 J/ cm2 in 0.5 J/ cm2 increments. Other adjacent sites will be treated with the same amount of light immediately after a short spray of a cooling agent.

Before, during, and after the laser pulses, epidermal temperatures will be measured. A compound germanium lens with unit magnification will image the infrared emission from the skin surface onto a 128x128 In Sb fast infrared focal plane array camera sensitive in the 3-5m spectral range with a temperature accuracy of 0.01C. Using white light flash from a camera to the study skin area making measurement as a means to get a quantitative assessment of Port Wine Stain color or redness.

Evaluated at each visit by searching for hypertrophic scarring, changes in skin pigmentation, atrophy or induration will be documented clinically, and by photography, and monitored until resolution.

Eligibility

Ages Eligible for Study:	7 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

primary care clinic, community sample

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 in 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 Medical Clinic

Investigators


Principal Investigator:	John S Nelson, M.D.,Ph.D	Beckman Laser Institute Medical Clinic

More Information

Responsible Party:	Beckman Laser Institute ( John S Nelson, M.D.,Ph.D )
Study ID Numbers:	RR-01192,AR-47551,AR-48458, Candela Laser Corp, P41-RR01192;NIH-LAMMP
First Received:	October 4, 2007
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00540917
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

Port Wine Stain Birthmark

Study placed in the following topic categories:

Skin Diseases

Nevi flammei, familial multiple

Port-Wine Stain

Connective Tissue Diseases

Skin Abnormalities

Infant, Newborn, Diseases

Congenital Abnormalities

Additional relevant MeSH terms:

Skin and Connective Tissue Diseases

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

ClinicalTrials.gov processed this record on May 15, 2008

Sponsors and Collaborators:	University of California, Irvine Beckman Laser Institute Medical Clinic
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00540917