NCT03776461已完成不适用
Clinical Evaluation of the Safety and Performance of Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Subject Satisfaction
研究概览
简要总结
Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of facial wrinkles.
详细描述
The study will evaluate 50 treatment sites in subjects requesting treatment of their facial wrinkles. The study will involve three treatments on both sides of the face with 3-5 week intervals between each treatment. Subjects will be followed at 6 and 12 weeks after their last treatment. Analysis will be performed on all subjects who receive at least one treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Evaluator blinded assessment of photographs
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, male or female subjects over 21 years of age who are seeking treatment and reduction of their facial wrinkles.
- •Able to read, understand and voluntarily provide written Informed Consent.
- •Able and willing to comply with the treatment/follow-up schedule and requirements.
- •Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study and have a negative Urine Pregnancy test at baseline.
排除标准
- •Implantable defibrillators, cardiac pacemakers, and other metal implants
- •Subjects with any implantable metal device in the treatment area
- •Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
- •Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
- •Current or history of any kind of cancer, or pre-malignant moles.
- •Severe concurrent conditions, such as cardiac disorders.
- •Pregnancy or intending to become pregnant during the study and nursing.
- •Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
- •History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only after a prophylactic regime has been followed for 2 weeks or longer prior to enrollment , or according to Investigator's discretion .
- •Poorly controlled endocrine disorders, such as diabetes.
- •Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
- •History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.
- •History of bleeding coagulopathies, or use of anticoagulants (excluding daily aspirin).
- •Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three months, if face is treated.
- •Use of isotretinoin (Accutane®) or other retinoids within six months prior to treatment or as per physician's discretion.
- •Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen-containing agents) one week before and after each treatment session.
- •Any surgical procedure in the treatment area within the last six months or before complete healing.
- •Treating over tattoo or permanent makeup.
- •Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.
- •As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.
结局指标
主要结局
Subject Satisfaction
时间窗: 6 Weeks Post Last Treatment (Around Week 14)
Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale (0=Very Unsatisfied, 4=Very Satisfied) at 6 weeks and 12 weeks post-treatment.
次要结局
- Subject Scale - 5 Point Scale for Treatment Tolerability With 0 Being Very Intolerable and 4 Very Tolerable.(Post Treatment at the Baseline, 4 Week and 8 Week treatment visits)
- Subject Scale - Visual Analog Scale for Pain(Post Treatment at the Baseline, 4 Week and 8 Week treatment visits)
研究者
研究点 (2)
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