Safety and Efficacy of Using LEORTEC-300 System For Hair Removal Treatment
Condition: Epilation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Removal of unwanted hair is one of the most commonly sought cosmetic solutions. Traditional
      methods, such as shaving, depilatories, tweezing and waxing result in only temporary hair
      removal, and thus require extensive maintenance. Long term hair removal via electrolysis is
      generally unsatisfactory due to its time consuming, painful nature and the associated risk of
      scarring or pigmentary changes. Moreover, the efficacy of electrolysis is user dependent and
      is estimated to be reduction of only 15-50% of the unwanted hair3.

      The more modern approach to long term hair removal involves laser and Intense Pulsed Light
      (IPL) treatment modalities. These technologies are based on the scientific principle of
      selective photothermolysis. During the treatment, the light energy is absorbed by the hair's
      pigment (melanin) and transmitted through the hair shaft to the follicle. Conversion of this
      energy into heat causes a rise in the hair temperature, leading to destruction of the
      follicle and disruption of the hair growth mechanism, while leaving the skin undamaged.

      Both laser and light devices have been proven successful in inducing permanent hair removal,
      as well as delayed hair growth, while causing minimal discomfort and complications. The light
      devices are based on the IPL technology, which differs from laser light in various physical
      aspects. The main difference is that while lasers emit light at a distinct wavelength, IPL
      delivers a wide range of wavelengths (400 1400 nm), thus allowing greater flexibility in
      aspects of body area, hair color and skin type LEORTEC LTD. has developed an innovative
      device that integrates the two treatment modalities: Laser and Intense Pulse Light (IPL) and
      in addition MLS - Multi Light Source- a combination of the two modalities. The purpose of
      this study is to evaluate the safety and efficacy of using Leortec 300 device for hair
      removal treatment.
    

Detailed description: 
      STUDY OBJECTIVES

        1. Primary Objective

             -  Safety

                  -  To evaluate the safety of using LEORTEC-300 System for hair removal treatment,
                     in different skin/hair colors and anatomical sites.

        2. Secondary Objectives

             -  Effectiveness

                  -  To assess the effectiveness of using the LEORTEC-300 system for hair removal
                     treatment in different skin/hair colors and anatomical sites.

                  -  Patient Satisfaction Immediately after the treatment patients will be asked to
                     rate pain level which they felt during the treatment.

                  -  Physician's Satisfaction Physician's satisfaction from the technique,
                     equipment and hair removal will be assessed by physician's questionnaire.

      STUDY DESIGN

      This is a two-sites, prospective, controlled study to further test the safety and
      effectiveness of the LEORTEC-300 system in hair removal treatment.

      SUBJECTS

      1.Source and Number Subjects for the study will be recruited from patients within the
      community who have sought treatment for hair removal from the investigative physicians and
      meet all of the eligibility criteria listed below. There will be a total of 30 patients.
    

Intervention name(s): Hair removal by laser/IPL device
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment