Port Wine Stain Clinical Trial
Official title:
Evaluation and Optimization of the Technical and Clinical Performance of the Lumenis ONE Platform
The Intense Pulsed Light (IPL) technology, by selective phototermolysis, is used for
eliminating, among other application, benign vascular lesions and unwanted leg veins. Light
energy heats the deeper structures of the skin. IPL devices provide a broad wavelength
spectrum of 515 to 1200 nm and fluence from 10 to 40 J/cm at o.5-1 Hz.The light is focused
by a reflector and then transmitted through various filters that cut off the lower
wavelength range of the emitted light; therefore, only those wavelengths longer than these
of the filters are transmitted.
objectives:
1. evaluate and optimize the clinical performance of the Luminis ONE platform for each of
the aforementioned clinical applications.
2. Reconfirm the parameter settings for each of the aforementioned clinical applications.
3. Confirm the user friendly design of the device, in aspects of software (user interface)
and various technical operational features.
Background:
The Intense Pulsed Light (IPL) technology, by selective phototermolysis, is used for
eliminating, among other application, benign vascular lesions and unwanted leg veins. Light
energy heats the deeper structures of the skin. IPL devices provide a broad wavelength
spectrum of 515 to 1200 nm and fluence from 10 to 40 J/cm at o.5-1 Hz.The light is focused
by a reflector and then transmitted through various filters that cut off the lower
wavelength range of the emitted light; therefore, only those wavelegths longer than these of
the filters are transmitted.
Material and Methods:
The luminis ONE medical system (Lumenis Ltd., Yokneam,Israel, and Pleasanton, CA, USA)
incorporate the non coherent pulsed light head.
Vascular lesion such as Telangiectases, leg veins or PWS will be treated with the IPL, with
the following filters :515,50,or 590.
Following every treatment the subjects will be asked how much pain was felt , using a score
of 1-5.
Photographs will be taken before each treatments . Every subject will be treated 5
treatments , with 5+1 weeks interval. clearance or improvement will be evaluated by the
physician at each visit,before the next treatment using the following scale:
1. No clearance
2. 0-25%
3. 25-50%
4. 50-75%
5. 75-100%
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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