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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 1, 2007 | ||||
| Last Updated Date | July 1, 2007 | ||||
| Start Date ICMJE | September 2007 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Hair, vascular lesions and wrinkles reduction as counted 1-3 months after each treatment session, depending on the treated area. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Measuring treatment discomfort as graded by the patients | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Enhanced Safety Aesthetic Laser System | ||||
| Official Title ICMJE | Peterio™ – an Add-on Device for Enhanced Safety of Aesthetic Laser Treatments | ||||
| Brief Summary | The purpose of this study is to determine whether a new laser system provides better safety and efficacy than existing lasers in popular cosmetic procedures such as hair removal, treatment of cosmetically disturbing vascular lesions and rhytides. |
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| Detailed Description | Cosmetic lasers are a well-established, popular modality for removal of unwanted hair, treatment of all types of vascular lesions, including hemangiomas, port wine stains, and a variety of telangiectases as well as facial rhytides reduction. The existing lasers are based on a wavelength that is specifically absorbed by the chromophore found in the target such as hair follicle, where the energy is converted to heat resulting in a thermal injury. However, the lasers for cosmetic treatments are not without limitations. A laser based long-term hair removal treatment is based on thermal destruction of the hair shaft and follicle using wavelengths that are specifically absorbed by the pigment melanin found in the hair follicle. The heating of hair follicle is done through heat dissipation from the hair shaft. One of the significant limitations of this approach is the fact that the epidermis through which the light energy must penetrate is rich in melanin and therefore absorbs a major portion of the energy, resulting in inadequate heating of the hair follicles. Similar problem exists when targeting other chromophores such as hemoglobin or water. The purpose of the study is an evaluation of safety and efficacy of a new laser based device. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Single Blind, Historical Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Device: Peterio | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Anderson RR, Parrish JA. Selective photothermolysis: precise microsurgery by selective absorption of pulsed radiation. Science. 1983 Apr 29;220(4596):524-7. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 25 | ||||
| Estimated Completion Date | September 2008 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00495443 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | Peterio-06 | ||||
| Study Sponsor ICMJE | Scilex Ltd. | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Scilex Ltd. | ||||
| Verification Date | July 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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