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Personalized Interactive Laser Therapy of Port Wine Stain

This study has been terminated.
(PI moved out of state.)
Sponsor:
Collaborators:
Arkansas Children's Hospital Research Institute
Children's University Medical Group
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00782483
First received: October 29, 2008
Last updated: June 19, 2014
Last verified: June 2014
  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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Personalized Interactive Laser Therapy of Port Wine Stain - Study 2

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • 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.


Enrollment: 6
Study Start Date: October 2008
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
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
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00782483     History of Changes
Other Study ID Numbers: 104344, UAMS Sponsored
Study First Received: October 29, 2008
Results First Received: January 6, 2014
Last Updated: June 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arkansas:
Diagnosis
Port Wine Stain
PWS

Additional relevant MeSH terms:
Port-Wine Stain
Congenital Abnormalities
Skin Abnormalities
Skin Diseases

ClinicalTrials.gov processed this record on November 20, 2014