Treatment of Port Wine Stains in Children With Pulsed Dye Laser and Timolol Gel (NCT01272609) | Clinical Trial Compass
TerminatedPhase 3
Treatment of Port Wine Stains in Children With Pulsed Dye Laser and Timolol Gel
Stopped: Rupture du traitement
France25 participantsStarted 2011-02-16
Plain-language summary
Pulsed dye laser (PDL)is the gold standard treatment of port wine stains (PWS). However, many sessions are required and failure or relapses are not uncommon. It has been demonstrated that a neoangiogenesis occurs after PDL, explaining at least partially those failure. The objective of this study is to evaluate the use of a topical beta-blocker (timolol 1% gel) as a combination treatment with PDL for treating PWS.
Methods. Prospective multicenter study comparing PDL alone to PDL + timolol. Sessions of PDL will be performed once a month for 3 months. One group will be treated with PDL alone and the other will also applied timolol 1% gel twice a day during treatment. The evaluation will be done one month after the third session.
Who can participate
Age range
6 Months – 18 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:
* Children from 6 months to 18 year-old.
* PWS of the face
* No prior treatement with PDL
* Membership or beneficiary of a national insurance scheme.
* Consent signed by the parents and by the patient if he is old enough to understand
Exclusion Criteria:
* Child with whom the angioma plan was already handled by laser or pulsed lamp
* Histories of asthma or obstructive bronchitis
* severe allergic Rhinitis and hyper bronchial ability to react
* Bradycardie sinusale, block auriculo-ventriculaires of the second or third degree
* unchecked Cardiac insufficiency
* cardiogenic Shock
* untreated Phéochromocytome
* Sentimentality in the timolol or in one of these excipients, and\\or in the other bétabloquants
* Taken by floctafénine or by sultopride
* Taken of bétabloquants by oral route, of inhibitors calcic or of amiodarone
* severe peripheral circulatory Disorders(Confusions of Raynaud)
* arterial Low blood pressure
* Pregnancy and feeding
* Absence of effective contraception at the girls old enough to procreate
* Contraindication in the use of cream with lidocaïne and with prilocaïne
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.