Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy of Using LEORTEC-300 System For Hair Removal Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00348257
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : February 28, 2007
Sponsor:
Information provided by:
Leortec Medical Systems Ltd

Tracking Information
First Submitted Date  ICMJE July 2, 2006
First Posted Date  ICMJE July 4, 2006
Last Update Posted Date February 28, 2007
Study Start Date  ICMJE July 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2007)
  • Hair removal efficiency 1- N1/N2 (N1 - Average number of hairs after the treatment
  • N2 - Average number of hairs before the treatment)
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00348257 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Using LEORTEC-300 System For Hair Removal Treatment
Official Title  ICMJE Safety and Efficacy of Using LEORTEC-300 System For Hair Removal Treatment
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilation
Intervention  ICMJE Device: Hair removal by laser/IPL device
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: July 2, 2006)
30
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE September 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy males/females between the ages of 18 to 70
  • Subject is willing to go trough hair removal treatment.
  • Subject understands the study procedure.
  • Subject is willing to sign the inform consent.
  • Subject must have the ability to comply with the study procedures and follow- up.

Exclusion Criteria:

  • Age < 18 years or > 70 years.
  • Use of medication for which 400nm to 1400nm light exposure is contraindicated
  • Coagulation disorder.
  • Infection / abscess / pains in treatment target area.
  • Recently tanned skin.
  • Photosensitivity or allergy.
  • Psoriasis.
  • Skin cancer.
  • Diabetes.
  • Pregnancy.
  • Tattoo on targeted area.
  • History of keloid scarring.
  • Use of aspirin or antioxidants
  • Eczema or dermatitis.
  • Subject is suffering extreme general weakness.
  • Subject objects to the study protocol.
  • Physician objection.
  • Known cognitive or psychiatric disorder
  • Participation in any other clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00348257
Other Study ID Numbers  ICMJE LEORTC-HR-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Leortec Medical Systems Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hanna Levy, PhD Leortec Medical Systems
PRS Account Leortec Medical Systems Ltd
Verification Date February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP