Evaluation of Safety and Efficacy of Using Venus Freeze™ (MP)2 V2 System for Wrinkles Rhytides and Cellulite Treatment - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- To evaluate the efficacy of the Venus system for wrinkles rhytides and temporary cellulite and circumference reduction treatment. Efficacy evaluation will include RF, Magnetic Pulse Field and vacuum technology.
研究概览
简要总结
Skin aging is a multifactorial process involving the 3 layers of the skin: Epidermis, dermis and hypodermis.
Radio-frequency (RF) devices have been used for many years for a variety of surgical applications. The energy delivery systems of these established monopolar devices used a 'conductive coupling' delivery system in which energy is concentrated at the periphery of the electrode.
Venus Concept has developed the Venus Freeze (MP)2 V2 system for wrinkles, rhytides and temporary cellulite and circumference reduction treatments. While treating wrinkles rhytides and cellulite, the treatments creates enough thermal effect to induce collagen remodeling with no ablative thermal damage in the epidermis or dermis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females age 30 and up
- •Subjects with Fitzpatrick 4 to 9 degrees of elastosis
- •Subject able to comprehend and give informed consent for participation in this study
- •Subject must commit to all treatments and follow-up visits
- •Subject must sign the Informed Consent Form
排除标准
- •Subjects with implanted pacemakers, arrhythmias or any other severe known heart disorder
- •Subjects with any implantable metal device in the treatment area
- •Subjects on any medication that would affect the characteristic of the skin (medical or hormonal), such as "Accutane", within the past 6 months or photosensitizing medications
- •Subjects that have had any other invasive or non invasive method of skin therapy or hair removal performed in the past 9 months (in the treated area) Subjects who are scheduled or planned for any other invasive or non invasive method of skin therapy or hair removal in the treated area at the period of the study
- •Subjects who have any form of malignant skin cancer on the treatment area
- •Subjects with history of keloid formations or hypertrophic scarring
- •Pregnant or lactating Subjects
- •Subjects with Epilepsy or severe migraines
- •Subjects with permanent makeup/ tattoo/ body piercing (in the treated area)
- •Subjects with any Infection / abscess / dermatitis/ pains in treatment target area.
- •Subjects who suffer from autoimmune disorders or diabetes
- •Subjects with clotting disorders
- •Subjects are suffering from psychiatric disorders and treated with psychiatric medications.
- •Subject is suffering extreme general weakness.
- •Subject objects to the study protocol
- •Concurrent participation in any other clinical study
- •Physician objection
结局指标
主要结局
To evaluate the efficacy of the Venus system for wrinkles rhytides and temporary cellulite and circumference reduction treatment. Efficacy evaluation will include RF, Magnetic Pulse Field and vacuum technology.
时间窗: 5 months
Efficacy will be established by skin improvement as a result of the treatment by validated scales. Results will be compared to control group results. The pre - and post-treatment photographs will be compared and assessed by three independent dermatologists.
次要结局
- To evaluate the safety of the Venus Freeze (MP)2 V2 system for wrinkles, rhytides, temporary cellulite and circumference reduction. Safety evaluation will include RF, Magnetic Pulse Field and vacuum technology.(5 months)