Evaluation of Safety and Efficacy of the Apollo™ System for Treatment of Wrinkles and Rhytides
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 4
- 主要终点
- To evaluate the safety of the apollo™ system for wrinkles and rhytides treatment.
研究概览
简要总结
Non-invasive, energy-based, aesthetic treatments are becoming increasingly popular among female and male patients of all ages. Different technologies are presently available to rejuvenate skin, including therapeutic ultrasound, lasers and intense pulsed light (IPL), however radiofrequency has emerged as the most effective and versatile modality for the broadest range of body and facial treatments, including non-invasive wrinkle treatment.
The apollo™ system is an RF system, based on the TriPollar™ technology. The technology is based on three or more electrodes designed to deliver RF current focused into the skin, thus generating heat in the dermal layer. Selective and focused electro-heating of the skin is intended to stimulate collagen remodeling in the dermal layer resulting in non invasive wrinkle treatment.
The apollo™ system is intended for use in dermatologic and general surgical procedures for non invasive treatment of facial wrinkles and rhytides. This study was designed in order to evaluate the safety and efficacy of the Apollo™ System for facial wrinkles and rhytides treatments.
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
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject read, understood and signed the Consent Form
- •Healthy female/male aged 35 65 years,
- •Fitzpatrick wrinkle classification score 4 and above
- •Subject is capable of reading, understanding and following instructions of the procedure to be applied.
- •Subject is able and willing to comply with the treatment and follow-up schedule.
排除标准
- •Subject has a pacemaker or internal defibrillator, implanted neurostimulators or any other internal electric device or patient who had an implant in the past.
- •Subject has metal or other implants in the treatment area (Not including dental fillings, implants and crowns).
- •Subject has current or history of cancer, especially skin cancer or premalignant moles or is undergoing any form of treatment for active cancer.
- •Subject has severe concurrent conditions such as epilepsy, lupus or cardiac disorders.
- •Subject has poorly controlled endocrine disorders such as diabetes.
- •Subject is female who is pregnant, lactating, or plans to become pregnant during the study period or had given birth less than 6 months ago.
- •Subject has an impaired immune system due to immunosuppressive diseases such as HIV or AIDS, or use of immunosuppressive medications.
- •Subject has a condition that could be negatively affected by heat, including any history of diseases stimulated by heat, such as recurrent Herpes Simplex (in the treatment area).
- •Subject has diminished or exaggerated perception of temperature changes.
- •Subject has significant concurrent skin conditions affecting areas to be treated such as sores, hemorrhages or risk of hemorrhages, septic conditions, psoriasis, eczema and rash as well as very dry and fragile skin.
- •Subject has history of collagen disorders, keloid formation and abnormal wound healing.
- •Subject has had previous invasive/ablative procedures in the areas to be treated within 3 months prior to initial treatment or plans on such treatment during the course of the study, or before complete healing has occurred.
- •Subject has had Botox injections in the treatment area within 6 months prior to initial treatment
- •Subject has had natural fillers within 9 months prior to initial treatment
- •Subject has synthetic fillers or gold/plastic threads in the treatment area.
- •Subject takes or has taken medications, herbal preparations, food supplements or vitamins that might cause fragile skin or impaired skin healing such as prolonged steroid regime, tetracyclines, or St. John's Wort for the last 3 months.
- •Subject has used oral isotretinoin (Accutane or Roaccutan) within 6 months prior to study enrollment or plans use during the course of the study.
- •Subject has history of bleeding coagulopathies or use of anticoagulants.
- •Subject has burned, blistered, irritated, or sensitive skin due to excessive fresh tanning in areas to be treated or is unlikely to refrain from excessive tanning during the study.
- •Concurrent participation in any other study.
- •Subject has mental disorders.
结局指标
主要结局
To evaluate the safety of the apollo™ system for wrinkles and rhytides treatment.
时间窗: 5 months
The safety of using the apollo™ system for wrinkles and rhytides treatment will be established by physician's assessment/observation of adverse events.
次要结局
- • To evaluate the efficacy of the apollo™ system for wrinkles and rhytides treatment.(5 months)