Completed

NCT Number: NCT00348257

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

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.

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Key information

Conditions

Epilation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Elisha Hospital

Haifa, 34636, Israel

About this study

STUDY OBJECTIVES

Primary Objective

Safety

To evaluate the safety of using LEORTEC-300 System for hair removal treatment, in different skin/hair colors and anatomical sites.
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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hair removal by laser/IPL device

Device

Primary outcomes

Hair removal efficiency 1- N1/N2 (N1 - Average number of hairs after the treatment
N2 - Average number of hairs before the treatment)

Sponsors and collaborators

Lead sponsor

Leortec Medical Systems Ltd

Industry

Registry information

Important dates

Study start: 2006
Study completion: 2006
First posted: Jul 4, 2006
Registry last updated: Feb 28, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.