NCT01559233已完成不适用
Clinical Study to Determine Safety and Efficacy of FPlus for Wrinkle Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Invasix
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Lack of adverse events during treatments with the FPlus device and 3 months following last treatment.
研究概览
简要总结
Patient demand for non-surgical, non-invasive, and no-downtime wrinkle and rhytides treatment procedures has grown dramatically over the past decade as new treatments and technologies have been introduced.
This study was performed in order to evaluate the efficacy and safety of the Invasix FPlus System, an innovative noninvasive system intended for wrinkles and rhytides treatment.
Subjects were treated for face wrinkles and rhytides reduction and followed for 3 months after last treatment. In order to evaluate treatment efficacy, pre and post treatment photos were introduced to three uninvolved physicians for blinded evaluation.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with mild to moderate facial wrinkles and rhytides .
- •Males and females 21 - 65 years of age.
- •Willingness to follow the treatment schedule, and have photographs taken.
排除标准
- •Pacemaker or internal defibrillator, or other implanted metallic or electronic device.
- •Permanent implant in the treated area such as metal plates and screws or silicon, unless deep enough in the periosteal plane.
- •Avoid treatment if intra-dermal or superficial sub-dermal areas have been injected with Botox/HA/collagen/fat injections or other augmentation methods with bio-material during last 6 months.
- •Current or history of skin cancer, or any other type of cancer, or pre-malignant moles.
- •Severe concurrent conditions, such as cardiac disorders.
- •Pregnancy or nursing.
- •Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
- •Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regime.
- •Poorly controlled endocrine disorders, such as diabetes.
- •Any active skin 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.
- •History of bleeding coagulopathies, or use of anticoagulants in the last 10 days.
- •Any facial surgery performed within 12 months prior to treatment.
- •Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last 3 months.
- •Having received treatment with light, laser, RF, or other devices in the treated area within 6 months.
- •Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
- •Treating over tattoo or permanent makeup.
- •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
Lack of adverse events during treatments with the FPlus device and 3 months following last treatment.
时间窗: 4.5 months
次要结局
- Facial wrinkle reduction rate following 6 treatments with the FPlus device, as agreed 3 blinded dermatologists, based on Fitzpatrick wrinkle and elastosis scale.(4.5 months)
研究者
研究点 (2)
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