Enhanced Safety Laser Hair Removal System

Peterio™ - an Add-on Device for Enhanced Safety of Aesthetic Laser Treatments.

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

Study Overview

• Status: Unknown
• Conditions: Hirsutism; Hypertrichosis
• Intervention / Treatment: Device: Peterio

Detailed 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.

• Study Type: Interventional
• Enrollment: 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leon Gilad, MD; Phone Number: 972-26235262; Email: leong@cc.huji.ac.il

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Hadassah Medical Center, Dermatology
    • Principal Investigator: Leon Gilad, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Secondary Outcome Measures

Outcome Measure
Measuring treatment discomfort as graded by the patients.

Collaborators and Investigators

• Sponsor: Scilex Ltd.
• Investigators: Principal Investigator: Leon Gilad, MD, Hadassah Medical Organization

Publications and helpful links

General Publications

• Anderson RR, Parrish JA. Selective photothermolysis: precise microsurgery by selective absorption of pulsed radiation. Science. 1983 Apr 29;220(4596):524-7. doi: 10.1126/science.6836297.

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Study Completion: April 1, 2008

Study Registration Dates

• First Submitted: February 27, 2007
• First Submitted That Met QC Criteria: February 27, 2007
• First Posted (Estimate): March 1, 2007

Study Record Updates

• Last Update Posted (Estimate): March 1, 2007
• Last Update Submitted That Met QC Criteria: February 27, 2007
• Last Verified: February 1, 2007

More Information

Terms related to this study

• Keywords: Hirsutism; Hypertrichosis
• Additional Relevant MeSH Terms: Skin Diseases; Hair Diseases; Virilism; Hirsutism; Hypertrichosis
• Other Study ID Numbers: Peterio-05