In Vivo Study to Evaluate Tissue Remodeling Via Fibroblast Stimulation Following a Single SofWave Treatment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Evaluate the biological responses
研究概览
简要总结
Open-label, non-randomized single-arm prospective, single-center, self-controlled clinical study.
详细描述
Eligible subjects will arrive for a screening visit, and if will be found eligible and will provide signed ICF, during this visit a biopsy will be taken from the pre-auricular area.
At the second visit, a week after the screening visit, sutures from the biopsy (if present) will be removed, and subjects will receive a single treatment on the full face, neck, and submental area using the SofWave system with the Lift applicator.
Subjects will return to the clinic for a follow-up visit at one of the following timepoints (2 subjects per timepoint): 5 days, 4 weeks ± 2 days, 8 weeks ± 2 days, 12 weeks ± 4 days, or 24 weeks ± 4 days post-treatment. During this visit, an additional biopsy will be taken from the opposite pre-auricular side to that used at the screening visit.
All subjects will arrive for an additional visit, a week after the follow-up visit, for suture removal (if will exist).
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 60 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 35-60
- •Non-Smoker.
- •Fitzpatrick skin type I-VI.
- •Desire to lift facial lax skin, neck and/or submental and/or to lift the eyebrow area and/or improve facial wrinkles appearance.
- •Willing to give biopsies.
- •Able and willing to comply with all visits, treatments and evaluation schedules and requirements (including providing biopsies).
- •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.
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.
- •Presence of active local skin disease that may alter wound healing.
- •Severe solar elastosis.
- •Currently a smoker or has a history of heavy smoking (25 cigarettes per day or more) 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.
- •Severe or cystic facial acne, and/or Accutane use during past 6 months.
- •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 facial area to be treated, including facial skin-tightening procedure within the past 6 months; injectable (Botox or fillers) of any type within the past 6 months; ablative or non-ablative resurfacing/rejuvenation laser treatment or light treatment within the past 6 months, dermabrasion or deep facial peels within the past 12 months; facelift, blepharoplasty, or brow lift (including contour threads) within the past 12 months.
- •Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant 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
lax tissue
干预措施: Sofwave (Device)
结局指标
主要结局
Evaluate the biological responses
时间窗: up to 24 weeks
Evaluate the biological responses of tissue inflammation, proliferation and remodeling via fibroblast stimulation following SofWave single treatment. Tissue biological responses will be correlated with the patients' skin laxity and global aesthetic improvement.
次要结局
未报告次要终点