Clinical Evaluation of the Safety and Benefits of the Milesman 445 nm Blue Laser on Inflammatory Acne Lesions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- How many lesions treated have disappeared
研究概览
简要总结
Acne treatment by laser or other light devices is a currently accepted procedure. It allows faster resolution of injuries, with fewer side effects and greater patient satisfaction.
The mechanism of action of the Milesman Blauman laser is based on diode laser technology that produces pulses of blue light with a wavelength of 445 nanometers, in the blue and visible spectrum. It combines the precision of laser technology by focusing energy on diseased areas.
详细描述
Introduction / Justification Acne vulgaris (AV) is a polygenic multifactorial disease of the pilosebaceous units, which leads to the formation of both non-inflammatory lesions (comedones) and inflammatory lesions (papules, pustules, nodules and cysts), which affects approximately 85% of the population .
Acne treatment by laser or other light devices is a currently accepted procedure. It allows faster resolution of injuries, with fewer side effects and greater patient satisfaction.
The mechanism of action of the Milesman Blauman laser is based on diode laser technology that produces pulses of blue light with a wavelength of 445 nanometers, in the blue and visible spectrum. It combines the precision of laser technology by focusing energy on diseased areas.
The MILESMAN Laser has been on the market for over two years and has been used for cosmetic purposes and has proven to be safe during that time on the market.
MAIN GOAL The main objective of this study is to describe the efficacy and safety of the device (Milesman Laser) as a treatment for inflammatory acne lesions (papules and pustules). To do this, we will measure the evolution of the number of injuries of this type on the patient, before and after the application of the laser.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults between 18 and 50 years old
- •Diagnosis of mild to moderate acne on the face
- •They must have 10 - 50 inflammatory lesions (papules and pustules) on the face
- •In general good health
排除标准
- •Allergies or light sensitivities.
- •Severe acne or pre-existing dermatological facial condition
- •Presence of cysts on the face
- •More than one nodule on the face
- •Having an uncontrolled disease or an immunodeficient disorder.
- •Being pregnant or lactating
- •Oral and / or topical antibiotic treatment in the last 2 weeks.
- •Current treatment with hormonal contraceptives.
- •Impossibility of avoiding excessive sun exposure and any light treatment or any similar pro-fessional or aesthetic procedure during the 15 days before and 15 days after treatment.
- •Previous history of poorly healed wounds, keloid formation, or bleeding disorders
- •Process of active or historical infection of herpes simplex.
- •Extreme sensitivity to hydroquinone or other bleaching agents.
- •Personal or family history of melanoma.
- •Dysplastic nevus.
结局指标
主要结局
How many lesions treated have disappeared
时间窗: 1 week
Number of lesions before laser vs. number of lesions after laser(72 h and 1 week ).
次要结局
- Number of participants with treatment-related adverse events as assessed by MedRA(2 weeks)