Enhanced Safety Laser Hair Removal System

Scilex

Status: Unknown

Conditions: Hypertrichosis; Hirsutism

Treatments: Device: Peterio

Study type: Interventional

Funder types: Industry

Identifiers

NCT00441948

Peterio-05

Details and patient eligibility

About

The purpose of this study is to determine whether a new laser system provides better safety and efficacy in hair removal than existing lasers.

Full description

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age between 18 and 75 years old
• Fitzpatrick skin types I to VI

Exclusion criteria

• Age below 18 or above 75 year old
• Use of photosensitive medications
• Photosensitive diseases
• Active infection of any type and active infection or or a history of Herpes Simplex in the treated site
• Exposure to sun or artificial tanning during the last 3-4 weeks

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind