Personalized Interactive Laser Therapy of Port Wine Stain

University of Arkansas6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Port Wine Stain

Interventions

ThermoVision A20M Infrared CameraDEVICE

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

ScleroPLUSDEVICE

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.

3D Digital CameraDEVICE

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

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (1)

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

Average Laser Setting to be Used to Treat Port Wine Stains as Measured by Mathematical Calculations Based on Imaging and Temperature Analysis of Malformation.

6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation.

Time frame: Three treatments up to one year, whichever is first

Data from ClinicalTrials.gov

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