Clinical Trial: Enhanced Safety Laser Hair Removal System
Study Status: Completed
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 in hair removal than existing lasers.
Detailed Summary:
Lasers are a well-established, popular modality for removal of unwanted hair. The existing lasers are based on a wavelength that is specifically absorbed by the pigment melanin found in the hair follicle, where the energy is converted to heat resulting in a thermal injury.
However, lasers for hair removal 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. The purpose of the study is an evaluation safety and efficacy of a new laser based device.
Sponsor: Scilex Ltd.
Current Primary Outcome:
- Hair reduction as counted 1-3 months after each treatment session, depending on the treated area.
- Long term clearance will be calculated as the ratio between the value of the baseline hair count taken immediately before the first treatment, and the value obtained at the 3-6 month post treatment hair count.
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: February 27, 2007
Date Started: May 2007
Date Completion: April 2008
Last Updated: February 27, 2007
Last Verified: February 2007
