Study Stopped
PI moved out of state.
Personalized Interactive Laser Therapy of Port Wine Stain
2 other identifiers
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 29, 2008
CompletedFirst Posted
Study publicly available on registry
October 31, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
July 21, 2014
CompletedJuly 21, 2014
June 1, 2014
4 years
October 29, 2008
January 6, 2014
June 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Average Laser Setting to be Used to Treat Port Wine Stains as Measured by Mathematical Calculations Based on Imaging and Temperature Analysis of Malformation.
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
Interventions
FLIR Systems, Boston, MA. This is a non invasive passive thermal imaging device with less than minimal risk to subjects and staff.
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.
3dMD, Atlanta, GA. Approved by the food and drug administration (FDA) for imaging patients and will be used as labeled.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Arkansaslead
- Arkansas Children's Hospital Research Institutecollaborator
- Children's University Medical Groupcollaborator
Study Sites (1)
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
PI relocated and protocol was terminated, and no subject returned for treatment under protocol.
Results Point of Contact
- Title
- Dr. Gal Shafirstein
- Organization
- University of Arkansas for Medical Sciences/Arkansas Children's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Gal Shafirstein, PhD
UAMS, ACH
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2008
First Posted
October 31, 2008
Study Start
October 1, 2008
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
July 21, 2014
Results First Posted
July 21, 2014
Record last verified: 2014-06