NCT04249115终止不适用
Prospective, Open-Label, Multi-Center, Non-Significant Risk Study of Nano-Pulse Stimulation™ (NPS™) Technology in Healthy Adults With Seborrheic Keratosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 175
- 试验地点
- 14
- 主要终点
- Clearance Rate of SK Lesions
研究概览
简要总结
Primary study objective is to evaluate the optimization of Nano-Pulse Stimulation (NPS) energy settings for lesion clearance of Seborrheic Keratosis (SKs) from off-facial areas of healthy adults.
详细描述
- Evaluate lesion clearance rate of SKs in off-face locations post-treatment versus baseline using multiple sized treatment tips with microneedles.
- Evaluate the clearance of the treated SKs using multiple energy settings at various time points initial procedure, compared baseline.
- Evaluate skin effects and adverse event rate.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female between 21 and 75 years of age
- •Voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained
- •Understanding of the clinical investigation, agree to cooperate with the investigational procedures and willing to return for all the required follow-up visits
- •Understands that SKs are to be treated in a single treatment session and is aware that they may receive a second treatment
- •Must be able to visit clinic site at 7-, 30-, 60-, and 90-days post-primary treatment of SK lesion and at retreatment
- •Clinical diagnosis of stable, clinically typical Seborrheic Keratosis
- •Minimum of two SK lesions
- •SKs must be no greater than 2mm in height and not exceed 10mm x 10mm at their largest point
- •Undergo all study procedures including consent for global photographs of the SK study sites
- •Agrees to refrain from using all other SK lesion removal products or treatments (topical medication including over-the-counter medications) during the study period
排除标准
- •Implantable electronic devices (i.e., automatic defibrillator)
- •Active infection or history of infection in designated test area within 90 days prior to first treatment
- •Not willing or able to sign the Informed Consent
- •Known to be immune-compromised
- •Known to be keloid producer
- •Taking blood thinning medications
- •Insulin dependent, Type I diabetics
- •Allergies to Lidocaine or Lidocaine-like products
- •Employed by the sponsor, clinic site, or entity associated with the conduct of the study
- •Family member of someone employed by the sponsor, clinic site, or entity associated with the conduct of the study
- •Have any condition or situation which, in the Investigator's opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study
- •Prior inability to complete required study visits during treatment period.
- •Use of any other investigational drug, therapy, or device within the past 30 days of enrollment or concurrent participation in another research study
结局指标
主要结局
Clearance Rate of SK Lesions
时间窗: 90 days post-last treatment
Degree of Clearance of SK lesion treated with NPS as rated by investigators.
次要结局
未报告次要终点
研究者
研究点 (14)
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