Safety and Efficacy of Using LEORTEC-300 System For Hair Removal Treatment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Hair removal efficiency 1- N1/N2 (N1 - Average number of hairs after the treatment
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Hair removal efficiency 1- N1/N2 (N1 - Average number of hairs after the treatment
N2 - Average number of hairs before the treatment)
次要结局
未报告次要终点
