- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00782483
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
-
-
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
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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