NCT04253418终止不适用
Prospective, Open Label, Multi-Center, Non-Significant Risk Study of Nano-Pulse Stimulation™ (NPS™ ) Technology in Healthy Adults With Sebaceous Hyperplasia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 125
- 试验地点
- 12
- 主要终点
- SH Lesion Clearance Rate
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 Sebaceous Hyperplasia (SH) lesions from facial areas of healthy adult subjects.
详细描述
- Evaluate lesion clearance of treated facial Sebaceous Hyperplasia lesions using multiple sized treatment tips with microneedles.
- Evaluate lesion clearance of the treated Sebaceous Hyperplasia lesions using multiple energy settings levels at various time points.
- 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 18 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 are willing to return for all the required follow-up visits.
- •Understands that SHs are to be treated in a single treatment session is aware that they may receive a second treatment at their third study visit
- •Must be able to visit clinic site at 7-, 30-, 60-days post-primary treatment of SH lesion and at 30- and 60-days post-retreatment.
- •Clinically diagnosis of typical sebaceous hyperplasia.
- •Minimum of four SH lesions.
- •Undergo all study procedures including consent for photographs of the treated SH sites.
- •Agrees to refrain from using all other SH 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., pacemaker, implantable cardioverter 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 a 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.
- •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.
- •Known 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
SH Lesion Clearance Rate
时间窗: 60-days post-last NPS treatment
Clearance of SH lesions treated with NPS as rated by investigators.
次要结局
未报告次要终点
研究者
研究点 (12)
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