Feasibility Study on Radiofrequency-Based Selective Electrothermolysis to Investigate Its Effects on Human Skin
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Tolerability of skin-RF interactions in axillary skin
研究概览
简要总结
This research is being done to assess the effect of radiofrequency (RF)-based treatment on skin and skin conditions.
详细描述
Radiofrequency (RF)-based selective electrothermolysis is an increasingly utilized minimally invasive technology for several dermatologic conditions, such as epilation, acne vulgaris, and skin rejuvenation, with minimal side effects. This procedure targets and destroys selective cutaneous and subcutaneous structures; therefore, allowing greater control and specificity of treatment area and minimizing destruction to surrounding tissue. Here, the investigators propose to utilize this technology on human axillary skin to establish safety and biologic effects of selective electrothermolysis in this particular area of the skin.
The investigators will assess the tolerability, safety, and histometric changes in skin-radiofrequency interactions in the axillary skin of participants. The investigators will collect skin samples from prospective volunteers and assess for biologic effects in human axillary skin after selective electrothermolysis treatment.
During the four months of study period, Participants in the study will receive clinical assessments, photography, questionnaires, up to 3 treatments of RF-based selective electrothermolysis to pre-selected areas of the axillary skin, up to 2 4-mm skin biopsies for up to 5 study visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For primary objective: healthy volunteers and HS patients between 22 and 70 years of age.
- •Participants must be healthy enough to undergo multiple skin biopsy in the opinion of the investigator.
- •Participants must provide informed consent.
- •Participants must have the ability and willingness to follow all study procedures, attend scheduled visits, and successfully complete the study.
- •Participants must have the ability to understand and communicate with the investigator.
- •For HS patients, participants will have localized disease to the axillae, mild to moderate severity and no evidence of active infection as assessed by the investigator
排除标准
- •Participants unable to provide informed consent.
- •Recently treated for current skin diseases that would affect clinical evaluation.
- •Known contraindications to selective electrothermolysis treatment.
- •Immunocompromised patients
- •Participants on systemic steroids
- •Participants on immune modulators
- •Participants on blood thinners
- •Participants with bleeding disorders
- •Participants with any active infections or currently treated infections
- •Participants with significant medical history or concurrent illness that the investigator feels is not safe for biopsy or study participation.
- •Noncompliant participants.
- •Pregnant or nursing participants (qualitative human chorionic gonadotropin (hCG) testing will be performed prior to each treatment).
- •Participants with allergy to anesthetics.
- •Participants with a history of keloids or hypertrophic scars within the past 10 years.
- •Participants who have taken oral/topical antihistamines, oral/topical analgesics, and/or other medications that the investigators believe will impact the study.
- •Participants who are currently taking or who have taken in the past 12 months any medications that may impair wound healing, such as systemic retinoids.
- •Participants who cannot undergo motor strength and sensory testing required to assess for adverse events in this study.
研究组 & 干预措施
Healthy Participants
Electrothermolysis treatment using varying levels of RF energies
干预措施: Radiofrequency-Based treatment (Device)
结局指标
主要结局
Tolerability of skin-RF interactions in axillary skin
时间窗: 4 months
Tolerability will be assessed by number of patients experiencing adverse events grade 2 or higher as defined by the Common Terminology Criteria for Adverse Events.
Safety of skin-RF interactions in axillary skin
时间窗: 4 months
Safety will be assessed by number of patients experiencing adverse events grade 2 or higher as defined by the Common Terminology Criteria for Adverse Events.
次要结局
未报告次要终点