Personalized Interactive Laser Therapy of Port Wine Stain

This study is currently recruiting participants.

Verified by University of Arkansas, October 2008

Sponsors and Collaborators:	University of Arkansas Arkansas Children's Hospital Research Institute Children's University Medical Group
Information provided by:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00782483

Purpose

Lasers are being used to treat Port Wine Stains (PWS), but the laser doesn't always work. Only about 10% of PWS can be completely cleared. The research team believes that the investigators can improve the response of PWS to laser therapy by using a computer program that the principal investigator of this study (Dr. Shafirstein PhD) has developed. The purpose of this study is to test the validity of this computer program. Personalized Interactive Laser Therapy (PILT) could significantly improve clinical outcomes of laser treatment of PWS.

Condition	Intervention
Port Wine Stain	Device: ThermoVision A20M Infrared Camera Device: ScleroPLUS Device: 3D Digital Camera

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Personalized Interactive Laser Therapy of Port Wine Stain - Study 2

Further study details as provided by University of Arkansas:

Primary Outcome Measures:

Port Wine Stains (PWS) Clearance [ Time Frame: Three treatments up to one year, whichever is first ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	15
Study Start Date:	October 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Intervention Details:

FLIR Systems, Boston, MA. This is a non invasive passive thermal imaging device with less than minimal risk to subjects and staff.

Sclerolaser, Candela Corp., Wayland, MA. This laser is approved by the food and drug administration (FDA) for treating PWS lesions and will be used as labeled.

3dMD, Atlanta, GA. Approved by the food and drug administration (FDA) for imaging patients and will be used as labeled.

Eligibility

Ages Eligible for Study:	3 Months to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosed with a PWS
At least one visible PWS measuring greater than or equal to 15 mm in diameter.
Information provided regarding alternative treatment methods, includig no treatment.
Reading, understanding, and signing of an informed consent document.
Children age 7 years or older has read, understood, and signed an assent document.
Agreement to participate in the study.
Agreement to return to at least 1 follow-up evaluation and treatment within 1 year after first treatment.
Zubrod performance status of 0 or 1 at screening.

Exclusion Criteria:

Inability or unwillingness of subject to participate in the study.
Inability or unwillingness of one parent or legal guardian of the subject to sign written informed consent document.
Subject can not return to at least 1 follow-up visit within 1 year, after the first treatment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782483

Contacts

Contact: Gal Shafirstein, PhD	501-526-4917	ShafirsteinGal@uams.edu
Contact: Jessica Blackwell, CRS	501-364-2018	BlackwellJessica@uams.edu

Locations

United States, Arkansas
Arkansas Children's Hospital	Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Jessica Blackwell, CRS 501-364-2018 BlackwellJessica@uams.edu
Contact: Jo McCallie 501-364-7546 McCallieMyraJ@uams.edu
Sub-Investigator: Lisa Buckmiller, MD

Sponsors and Collaborators

University of Arkansas

Arkansas Children's Hospital Research Institute

Children's University Medical Group

Investigators

Principal Investigator:	Gal Shafirstein, PhD	UAMS, ACH
Study Director:	Jessica Blackwell, CRS	UAMS, ACH

More Information

Responsible Party:	University of Arkansas, Arkansas Children's Hospital ( Dr. Gal Shafirstein )
Study ID Numbers:	104344, UAMS Sponsored
Study First Received:	October 29, 2008
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00782483
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Arkansas:

Diagnosis
Port Wine Stain
PWS

Study placed in the following topic categories:

Skin Diseases
Nevi flammei, familial multiple
Port-Wine Stain
Skin Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on January 16, 2009