Clinical Evaluation of Silk'n Glide for Face
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 主要终点
- 1. Comparison of Hair Counts Before Treatments to 4 and 12 Weeks Follow up Visits.
研究概览
简要总结
This is a clinical study to determine the efficacy and safety of the Glide, hair removal photo-depilation device, for removing facial hairs. During the first stage, the subjects will perform up to 6 face treatments, two weeks apart. The treatment's safety and efficiency will be evaluated at 4 weeks of after last treatment and at 12 weeks after last treatment.
详细描述
Study efficacy assessment:
Comparison of hair counts before treatments to 4 and 12 weeks follow up visits.
Study safety assessment:
- Reported errors and near errors using the device
- Device malfunctions which relate to device safety
- Device related adverse events
- Non device related adverse events (secondary endpoint)
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
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of unwanted hairs on the face
- •Skin Type I to IV (Fitzpatrick)
- •Adults older than 21 years of age but not more than 60 years of age.
- •Must be either post-menopausal or surgically steri-lized, or using a medically acceptable form of birth control (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or absti-nence).
- •Informed consent agreement by the subject.
- •Willingness to follow the treatment schedule and post treatment care.
排除标准
- •Malignant or pre-malignant pigmented lesions in the area to be treated.
- •Scarring or infection of the area to be treated.
- •Known photosensitivity.
- •Pregnancy or lactating
- •Subjects with Diabetes (Type I or II).
- •Presence of a suntan in the area to be treated.
- •Use of medication known to induce photosensitivity.
- •Subject is on anticoagulative medication or throm-boembolic condition.
- •Subjects with a pacemaker or internal defibrillator.
- •Use of NSAIDS two weeks prior to, and two weeks following the treatment.
- •Subjects that use waxing or other methods of photo-epilation 3 months prior to treatment.
- •Subjects that have been exposed to strong sunlight or an artificial tanning machine during the past 4 weeks
- •Subjects wearing a tattoo or permanent makeup on the area to be treated
- •Subjects with dark brown or black spots, such as large freckles, birth marks, moles or warts on the area to be treated
- •Subjects with Eczema, psoriasis, lesions, open wounds or active infections, such as cold sores in the area to be treated
- •Subjects with history of keloidal scar formation
- •Subjects with history of herpes outbreaks in the area of treatment, unless you have consulted your physician and received preventative treatment before using GlideTM
- •Subjects with epilepsy
- •Subjects using incontinence device, insulin pump, other active devices [NB: Protocol excludes pace-makers and internal defibrillators.]
- •Subjects with a history of skin cancer or areas of po-tential skin malignancies
- •Subjects who have received radiation therapy or chemotherapy treatments within the past 3 months
研究组 & 干预措施
Percentage of hair reduction
This is an open label, prospective study to evaluate safety and efficiency of Silk'n Glide on the face. During the study, the subjects will perform up to 6 face treatments, two weeks apart. The treatment's safety and efficiency will be evaluated at 4 weeks of after last treatment and at 12 weeks after last treatment .
干预措施: Glide (Device)
结局指标
主要结局
1. Comparison of Hair Counts Before Treatments to 4 and 12 Weeks Follow up Visits.
时间窗: 4 weeks and 12 weeks post treatment
Hair count is going to be preformed and base line and compare with the count at 4 weeks and 12 weeks. % of hair reducation is going to be calculated.
次要结局
未报告次要终点