NCT03945422已完成不适用
The Use of Radio Frequency in Premature Jowl and Neck Laxity Following Facialplasty
InMode MD Ltd.2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2019年4月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Change in skin appearance
研究概览
简要总结
Study is to evaluate the efficacy of treatment Radio Frequency in premature jowl and neck laxity following facialplasty
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult females and males between the ages of 40-80 inclusive, having premature jowl and/or neck laxity one to fifteen years following facialplasty, seeking skin tightening treatments.
- •Lack lipodystrophy in the jowl or neck area or at least not amenable to liposuction improvement (not a candidate for liposuction).
- •Lack of previous Face Lift complications (no nerve injury or hematoma history).
- •The patients should understand the information provided about the investigative nature of the treatment, possible benefits and side effects, and sign the Informed Consent Form, (including thepermission to use photography).
- •The patients should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other aesthetic treatment methods for the last 6 months and during the entire study period.
排除标准
- •Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
- •The Handpiece should be used at least 1cm away from cochlear implants in the ear.
- •Superficial permanent implant in the treated area such as metal plates and screws, metal piercing, silicone implants or an injected chemical substance.
- •Current or history of skin cancer (remission of 5 years), or current condition of any other type of cancer, or pre-malignant moles.
- •Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
- •Pregnancy and nursing.
- •History of bleeding coagulopathies or use of anticoagulants
- •Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications.
- •Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonalvirilization.
- •Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
- •History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
- •Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
- •Any surgery or treatment such as laser or chemicals in treated area within 3-6 months prior to treatment or before complete healing.
- •Allergies, in particular to anesthesia.
- •Mental disorders such as Body Dysmorphic Disorder (BDD).
- •As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient.
结局指标
主要结局
Change in skin appearance
时间窗: 3 months, 6 month, 9 months
Photos from all time points (baseline and follow-up visits) will be evaluated by the treating physician and 2 independent evaluators.
次要结局
- Investigator assessment of the skin appearance(3 Month, 6 Months, 9 Months)
- Optional: 3D Photographic analysis(3 months, 6 month, 9 months)
- Evaluate changes in skin appearance comparing photographs using Mechanical Turk (MTurk). The pictures will be sent through the system and evaluated by crowd workers.(3 Months, 6 Months)
研究者
研究点 (2)
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