Evaluation of Nano-Pulse Stimulation (NPS) in Patients With Seborrheic Keratosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 8
- 主要终点
- Clearance of SK Lesions
研究概览
简要总结
The primary purpose of this trial is to evaluate Nano-Pulse Stimulation (NPS) to clear or remove Seborrheic Keratosis (SK) lesions from off-facial areas of healthy adult subjects.
详细描述
Evaluate Nano-Pulse Stimulation (NPS) to clear or remove Seborrheic Keratosis (SK) lesions from off-facial areas of healthy adult subjects.
The specific objectives of this study are to:
- Document the non-treated appearance of off-face SKs.
- Evaluate the clearance of SKs in off-face locations post-treatment versus pre-treated appearance of the same lesion.
- Evaluate the clearance of the treated SKs at various points in time over several weeks following the initial procedure, compared to the pre-treated SKs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
A Reference Key was developed for 3 independent reviewers to use during their review of the full set (196 image pairs) of study photographs. The reference key included 2 representative photographs for each of the 4 possible scores used in the SK study (clear, mostly clear, partially clear, and not clear). The three independent reviewers were not principal investigators at enrolling centers.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing to sign the informed consent
- •Has a clinical diagnosis of stable, clinically typical seborrheic keratosis
- •Medically determined candidate for at least 4 off-face SK lesions
- •Must have at least four treatable SK lesions and be willing to have NPS treatment on any three of the four treatable SK lesions. Treatable SK lesions must: be at least 1 mm in height, and no greater than 3 mm in height and not have a dimension perpendicular to the longest dimension of greater than 7.5mm or longer in any dimension than 20mm
- •Willing to have three of the designated SK lesions treated in a single treatment session
- •Willing to return to the PI's office for five additional study visits at specified intervals over 106-days
- •Agrees to high resolution photos of both the treated SK lesions and the untreated SK lesion
- •No subject identity will be possible via the "lesion-only" photograph
- •No evidence of active infection in the designated tissue prior to treatment
- •Is not allergic to Lidocaine or Lidocaine-like products
- •Not pregnant or lactating
排除标准
- •Has an implantable electronic device (e.g., automatic defibrillator)
- •Active infection or history of infection within 90 previous days in designated test area
- •Not willing or able to sign the Informed Consent
- •Non-English speaking or reading
- •Is known to be immune-compromised
- •Known to be a keloid producer
- •On blood thinning medications
- •Diseases, conditions, or situations wherein the PI judges that the patient is not appropriate for participation in the study
结局指标
主要结局
Clearance of SK Lesions
时间窗: 106-day post-treatment
Total Number of treated SK lesions per participant rated as clear or mostly-clear by the Principal Investigator at each clinical site.
次要结局
未报告次要终点