Clinical Trial: Enhanced Safety Aesthetic Laser System

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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.

Detailed Summary: 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.
Sponsor: Scilex Ltd.

Current Primary Outcome: Hair, vascular lesions and wrinkles reduction as counted 1-3 months after each treatment session, depending on the treated area.

Original Primary Outcome: Same as current

Current Secondary Outcome: Measuring treatment discomfort as graded by the patients

Original Secondary Outcome: Same as current

Information By: Scilex Ltd.

Dates:
Date Received: July 1, 2007
Date Started: September 2007
Date Completion: September 2008
Last Updated: July 1, 2007
Last Verified: July 2007