Personalized Interactive Laser Therapy of Port Wine Stain

June 19, 2014 updated by: University of Arkansas

Personalized Interactive Laser Therapy of Port Wine Stain - Study 2

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Laser Setting to be Used to Treat Port Wine Stains as Measured by Mathematical Calculations Based on Imaging and Temperature Analysis of Malformation.
Time Frame: Three treatments up to one year, whichever is first
6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation.
Three treatments up to one year, whichever is first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Collaborators

Arkansas Children's Hospital Research Institute
Children's University Medical Group

Investigators

  • Principal Investigator: Gal Shafirstein, PhD, UAMS, ACH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

October 29, 2008

First Submitted That Met QC Criteria

October 29, 2008

First Posted (Estimate)

October 31, 2008

Study Record Updates

Last Update Posted (Estimate)

July 21, 2014

Last Update Submitted That Met QC Criteria

June 19, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104344
  • UAMS Sponsored

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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