Personalized Interactive Laser Therapy of Port Wine Stain

Not Applicable

Terminated

• Conditions: Port Wine Stain

• Registration Number: NCT00782483
• Lead Sponsor: University of Arkansas

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-29
• Study First Submitted QC: 2008-10-29
• Study First Posted: 2008-10-31
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Results First Submitted: 2014-01-06
• Status Verified: 2014-06
• Results First Submitted QC: 2014-06-19
• Last Update Submitted: 2014-06-19
• Results First Posted: 2014-07-21
• Last Update Posted: 2014-07-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States