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: October 25, 2012
Last verified: October 2012

October 29, 2008
October 25, 2012
October 2008
October 2012   (final data collection date for primary outcome measure)
Port Wine Stains (PWS) Clearance [ Time Frame: Three treatments up to one year, whichever is first ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00782483 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Personalized Interactive Laser Therapy of Port Wine Stain
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Port Wine Stain
  • 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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
October 2012
October 2012   (final data collection date for primary outcome measure)

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.
Both
3 Months to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00782483
104344, UAMS Sponsored
Yes
University of Arkansas
University of Arkansas
  • Arkansas Children's Hospital Research Institute
  • Children's University Medical Group
Principal Investigator: Gal Shafirstein, PhD UAMS, ACH
University of Arkansas
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP