Personalized Interactive Laser Therapy of Port Wine Stain (NCT00782483) | Clinical Trial Compass
TerminatedNot Applicable
Personalized Interactive Laser Therapy of Port Wine Stain
Stopped: PI moved out of state.
United States6 participantsStarted 2008-10
Plain-language 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.
Who can participate
Age range
3 Months – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.
Timeframe: Three treatments up to one year, whichever is first