Evaluation of SofWave Sofware-Guided Energy Delivery for Lower Face and Neck Rejuvenation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluate the clinical efficacy of the treatment for lower face and upper neck rejuvenation
研究概览
简要总结
Non-randomized single-arm prospective clinical study.
详细描述
Eligible subjects will receive 1 or 2 SofWave treatments (4-6 weeks apart) using the Total Treatment Energy (TTE) methods and will return to 3 follow up visits: at 4 weeks ± 2 weeks post last treatment (FU1), at 12 weeks ± 2 weeks post last treatment (FU2) , at 24 weeks ± 4 weeks post last treatment (FU3).
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
- 40 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy female and male subjects between the ages 40-
- •Non-Smoker.
- •Fitzpatrick skin type I-VI.
- •Desire to lift facial lax skin, neck and/or submental and/or improve facial wrinkles appearance.
- •Presence of mild to moderate laxity in the lower face and submental area.
- •Able and willing to comply with all visits, treatments and evaluation schedules and requirements.
- •Able to understand and provide written Informed Consent.
- •Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment.
- •Subject agrees not to undergo any other facial cosmetic treatment for a period of 3 months following last SofWave treatment.
- •Stable weight over the last 12 weeks and throughout the duration of the study.
- •Subjects agree to adhere to safe sun practices and daily use of broad-spectrum sunscreen SPF 30+.
- •Male subjects with facial hair in the treatment area are willing to trim or shave as needed to allow consistent standardized photography.
排除标准
- •Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
- •Presence of any active systemic or local infections.
- •Open wounds or lesions within the intended to treat area.
- •Tattoo or former tattoo at or near treatment area.
- •Presence of active local skin disease that may alter wound healing.
- •Uncontrolled diabetes mellitus.
- •Skin cancer in the area to be treated. History of any other non-melanoma skin cancers in the past 5 years within the treatment area (head and neck).
- •Severe solar elastosis.
- •History of smoking in the past 10 years.
- •History of chronic drug or alcohol abuse.
- •Excessive subcutaneous fat on the cheeks.
- •Significant scarring in the area to be treated or history of keloids.
- •Severe or cystic facial acne, and/or Accutane use during the past 6 months.
- •Pacemakers and electronic device implants in the treated area.
- •Presence of a metal stent or implant in the facial area (dental implants and/or braces are not excluded).
- •Inability to understand the protocol or to provide a signed informed consent.
- •History of cosmetic treatments in the area to be treated including:
- •Chemical peels, microneedling, dermabrasion, energy-based devices, or laser treatments in the past 6 months
- •Injectable filler treatments in the past 6 months
- •Injectable neuromodulator treatment in the past 4 months
- •Cosmetic surgical procedures in the treatment area, including but not limited to facelift in the past 12 months.
- •Taking anti-platelet or anti-coagulant within the past 2 weeks.
- •Ongoing use of psychiatric medication; taking psychiatric drugs within the past 2 weeks.
- •As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
研究组 & 干预措施
Experimental: lax tissue
干预措施: SofWave (Device)
结局指标
主要结局
Evaluate the clinical efficacy of the treatment for lower face and upper neck rejuvenation
时间窗: 12 weeks post treatment follow-up visit
Rate of the Improvement in the appearance of lower face and upper neck rejuvenation following SofWave treatment based on Global Aesthetic Improvement Scale (-1=worse, 0=no change, 1=improved, 2=marked improvement, 3=very much improved)
Lower face and upper neck rejuvenation
时间窗: 12 weeks post treatment follow-up visit
Evaluate the clinical efficacy of the treatment for lower face and upper neck rejuvenation, as assessed by the study physician using Physician Global Aesthetic Improvement Scale (GAIS; (-1=worse, 0=no change, 1=improved, 2=marked improvement, 3=very much improved)) at 12 weeks follow-up visit.
次要结局
未报告次要终点