Safety and Efficacy of Sofacia Treatment to Improve Facial Lines and Wrinkles, to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in lift of lax tissue
研究概览
简要总结
Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with masked evaluation.
详细描述
Eligible patients will receive 2 face and neck treatments (4-6 weeks ± 2 weeks apart) using the SofWave System. Each investigational site would treat the full face and submental zones including 1. The forehead and temples (left and right including the peri orbital zone) to lift the eyebrows 2. The cheeks (left and right including perioral zone and nasolabial folds) 3. Submental and sides of the neck (left and right) to lift lax skin.
All patients will return to the clinic for two follow up visits: 1. 7 days (FU1) post the first treatment (Tx.1). 2. 3 months ± 2 weeks post last treatment (FU2).
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 80 Years（Adult, Older 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-
- •Non-Smoker.
- •Fitzpatrick skin type I-VI.
- •Desire to lift lax skin in the neck and submental and/or to lift the brows.
- •Able and willing to comply with all visit, treatment 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.
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.
- •History of smoking in 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, acutance uses 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 give informed consent.
- •History of cosmetic treatments in the facial area to be treated, including facial skin-tightening procedure within the 6 months ; injectable (Botox or fillers) of any type within the 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.
结局指标
主要结局
Change in lift of lax tissue
时间窗: 3 and 6 months post last treatment
As assessed by independent masked evaluators. Quantitative image analysis to objectively measure change in lift of the eyebrow and submental and neck lax tissue would be conducted by comparing baseline images to those taken at each visit post FU1 (Pre Tx.2, FU2)
次要结局
未报告次要终点