Epilation Clinical Trial
Official title:
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | September 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Elisha Hospital | Haifa |
| Lead Sponsor | Collaborator |
|---|---|
| Leortec Medical Systems Ltd |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Hair removal efficiency 1- N1/N2 (N1 - Average number of hairs after the treatment | |||
| Primary | N2 - Average number of hairs before the treatment) |