Clinical Evaluation of the Safety and Performance of Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Facial Wrinkles at 12 Weeks Post Final Treatment Compared to Baseline
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 15 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. An additional histological analysis will be conducted including up to 12 of the participating subjects.
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 systemic retinoids within six months or topical retinoids within three 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
Change in Facial Wrinkles at 12 Weeks Post Final Treatment Compared to Baseline
时间窗: 12 Weeks Post Final Treatment
Change in facial wrinkles at 12 weeks post-treatment compared to baseline as assessed by blinded evaluators by photographic assessment utilizing the 9-point Fitzpatrick Wrinkle and Elastosis Scale (FWES). Scores of 1-3 indicate fine wrinkles with mild elastosis, scores 4-6 fine to moderate depth wrinkles with moderate elastosis and 7-9 fine to deep wrinkles with severe elastosis.
次要结局
- Subject Satisfaction(12 Weeks Post-Final Treatment)
- Subject Scale - Visual Analog Scale for Pain(An average of all 3 treatments)
- Subject Scale - 5 Point Scale for Treatment Tolerability(An average of all 3 treatments)