The Clinical Efficacy And Safety Of SkinStylus Microneedling System for Ventral Torso Hypertrophic Scars: Clinical Results With 30 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Number of Participants With Improvement Assessed Using the VAS Scar Scoring System
研究概览
简要总结
The purpose of the trial is to provide objective evidence the SkinStylus may be used safely and effectively for the treatment of ventral torso hypertrophic scars.
详细描述
- The SkinStylus has been designated as a non-significant risk and therefore will be granted an Investigational Device Exemption (IDE). There are no meaningful changes to the SkinStylus® instructions for use and specifically no new risks will be introduced.
- Each participant shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs. At the conclusion of the trial all participants shall be provided with a cross over treatment on the non-treated portion of the scar identical to that which was provided within the trial for the purpose of "evening" the ventral torso hypertrophic scar. This is entirely voluntary and participants may decline the treatment if they wish.
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
盲法说明
- The trial shall be blinded and bias minimized in that three (3) physicians who are either dermatologists or plastic surgeons (and not affiliated with the trial or Esthetic Education LLC) shall review the baseline and treatment photographs and score them using the VAS scale (Visual Analogue Scale).
入排标准
- 年龄范围
- 23 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at least 23 years old
- •shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs.
- •The scar(s) must present along a flat surface suitable for application of the SkinStylus® device and consistent medical photography.
排除标准
- •Pregnancy or chance of pregnancy
- •Currently taking Coumadin/Warfarin® or heparin
- •Diagnosis of any type of bleeding disorder
- •Any history of keloid formation
- •Lidocaine, tetracaine, prilocaine, bupivacaine, or benzocaine hypersensitivity
- •Diagnosis of mental disorders requiring inpatient treatment
- •Presence of metal implants around the proposed treatment areas
- •Diagnosis of any undefined wasting disease (Cachexia for example)
- •Diagnosis of an active infection in the treatment area other than mild acne
- •Diagnosis of the presence of tumors or those who are being treated by chemotherapy or radiation therapy
- •Diagnosis of severe cardiovascular and cerebrovascular disease
- •Diagnosis of renal failure
结局指标
主要结局
Number of Participants With Improvement Assessed Using the VAS Scar Scoring System
时间窗: 90 days from date of last treatment
The Visual Analog Scale Scar Scoring System (VAS Scar Scale) is a validated scar assessment scale with a minimum scar improvement value of 0.0 cm on one end of a 10.0 cm long line and 10.0 cm on the other end. The 0.0 cm represents "no change" in the appearance of the scar while 10.0 cm represents "complete resolution" of the scar. A panel of 3 expert graders viewed images of the treatment area and the control area before treatment and 90 days after the last treatment. The difference between the measurements taken at baseline and measurements taken two weeks following the end of the treatment of the treatment area was calculated for each participant, for each grader. The difference of all three graders analysis for each subject was averaged. Those participants with a VAS score on the treatment side that met the MCID of an improvement of at least 1.0 cm were identified in the results as "responders". A higher score is a better outcome.
次要结局
- Number of Patients Self-Reporting Improvement Using the Validated Self-Assessed Scar Improvement Scale Satisfaction Survey(90 days from date of last treatment)