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Sponsors and Collaborators: |
Rambam Health Care Campus Lumenis Ltd. |
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Information provided by: | Rambam Health Care Campus |
ClinicalTrials.gov Identifier: | NCT00247299 |
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:
Condition | Intervention |
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Telangiectases Port Wine Stain |
Device: IPL Quantum Product manufactured by Luminis Ltd. |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Evaluation and Optimization of the Technical and Clinical Performance of the Lumenis ONE Platform |
Estimated Enrollment: | 30 |
Study Start Date: | May 2005 |
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
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:
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Israel | |
Plastic surgery dept., Rambam medical center | |
Haifa, Israel, 9602 |
Principal Investigator: | Yehuda Ullmann, MD | Plastic Surgery Dept., Rambam Medical Center., Haifa,Israel |
Study ID Numbers: | danaCTIL, danaCTIL |
Study First Received: | October 30, 2005 |
Last Updated: | October 30, 2005 |
ClinicalTrials.gov Identifier: | NCT00247299 History of Changes |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Vascular lesions Intense pulse light phototermolysis |
wavelength filters non coherent |
Skin Diseases Nevi Flammei, Familial Multiple Port-Wine Stain Telangiectasis |
Skin Abnormalities Vascular Diseases Congenital Abnormalities |
Skin Diseases Port-Wine Stain Telangiectasis Skin Abnormalities |
Vascular Diseases Cardiovascular Diseases Congenital Abnormalities |