Change in Skin Elasticity After Combined Radiofrequency and Electromagnetic Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in Facial Skin Elasticity
研究概览
简要总结
This study will measure the difference in skin elasticity in females only before and after treatment with radiofrequency and pulsed electromagnetic field therapy.
详细描述
This study is an open-label, baseline-controlled, single-center study to measure the change in skin elasticity after combined radio frequency (RF) and pulsed electromagnetic field (PEMF) treatment. Forty-five adult females will undergo weekly treatments over a period of 8 weeks. Skin elasticity will be measured by a Cutometer® prior to beginning treatment, week 7 and 3 months after completion of treatment. Photographs will be taken prior to treatment, at week 4, week 7 and 3 months after completion of treatment. Patient discomfort/pain and satisfaction questionnaires will be completed before, during and after treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy adult female subject, 18 years of age and older with Fitzpatrick skin types I-IV
- •Ability to tolerate the RF/PEMF procedure, and willing to adhere to the treatment regimen
排除标准
- •Having any active electrical implant or permanent implant anywhere in the body, e.g. pacemaker, internal defibrillator
- •Prior use of retinoids in treated area within 2 weeks of initial treatment
- •Use of oral Isotretinoin (Accutane®) within 6 months of initial treatment
- •Patient on systemic corticosteroid therapy 6 months prior to start of study
- •Prior use of collagen, fat injections and /or other methods of skin augmentation (enhancement with injected or implanted material) in treated area within 4-6 weeks of initial treatment. Treatment may not be performed at all over permanent dermal implants.
- •Prior ablative resurfacing procedure in treated area with laser or other devices within 12 months of initial treatment
- •Any other surgery in treated area within 12 months of initial treatment
- •History of keloid formation or poor wound healing in a previously injured skin area
- •Epidermal or dermal disorders
- •Open laceration or abrasion of any sort on the area to be treated.
- •History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
- •Having any form of active cancer at the time of enrollment
- •Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the Investigator would interfere with the treatment, or healing process
- •Participation in a study of another device or drug within 1 month prior to study enrollment
- •Tattoos in the treatment area.
结局指标
主要结局
Change in Facial Skin Elasticity
时间窗: 20 weeks after the last study treatment
A Cutometer® will be used to measure the change in gross elasticity (R2) of the facial skin as calculated by Ua/Uf which is a ratio of maximum recovery (Ua) and skin distensibility (Uf). The value is expressed as a percentage, the closer the value is to 1 (100%), the more elastic the skin.
次要结局
- Improvement in Subject Satisfaction With Facial Skin Laxity Compared to Baseline as Measured by the 5-point Likert Satisfaction Scale(7 weeks and 20 weeks post study treatments)
- General Aesthetic Improvement Scale (GAIS)(7 weeks and 20 weeks post study treatments.)