Personalized Interactive Laser Therapy of Port Wine Stain

NCT00782483 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2014-07-21

Study results available
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Summary

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.

Conditions

  • Port Wine Stain

Interventions

DEVICE

ThermoVision A20M Infrared Camera

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

DEVICE

ScleroPLUS

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.

DEVICE

3D Digital Camera

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

Sponsors & Collaborators

  • Arkansas Children's Hospital Research Institute

    collaborator OTHER
  • Children's University Medical Group

    collaborator OTHER
  • University of Arkansas

    lead OTHER

Principal Investigators

  • Gal Shafirstein, PhD · UAMS, ACH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00782483 on ClinicalTrials.gov