Safety and Efficacy of SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 5
- 主要终点
- Efficacy Masked Evaluators Evaluations: assessed by independent masked evaluators
研究概览
简要总结
This is a prospective, open label, multi-center, self-controlled clinical study to demonstrate the safety and efficacy of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow.
详细描述
This is a prospective, open label, multi-center, self-controlled clinical study to demonstrate the safety and efficacy of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow.
Up to 112 healthy candidates who are seeking treatment from participating investigators will be enrolled at up to 5 participating study sites. Patients will receive 2 treatments (4-6 weeks ± 2 weeks apart) with the SofWave system and will be followed up to 3 months post the 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 Epileptic seizures.
- •History of severe migraine tendency.
- •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.
- •Inability to understand the protocol or to give informed consent.
- •On-going use of psychiatric medication.
- •History of cosmetic treatments in the facial area to be treated, including facial skin-tightening procedure within the past year; injectable filler of any type within the past year; Botox or fillers in the lower face 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 psychiatric drugs, 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
Sofwave Treatment
In this arm (single) patients would be treated twice with Sofwave on the face and/or submental and neck.
干预措施: Sofwave Treatments (Device)
结局指标
主要结局
Efficacy Masked Evaluators Evaluations: assessed by independent masked evaluators
时间窗: 3 months post last treatment follow up visit
Evaluate the clinical efficacy of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow, as assessed by independent masked evaluators. The two independent masked evaluators would be delivered a presentation with images randomly ordered for 'before' and 'after'. Each investigator would have to guess the correct 'after' image. Both investigators must agree on more than 50% of the cases to match success criteria. Each treated zone (Eyebrows, Neck \& Submental) would be ranked individually. The primary endpoint would only be achieved along with success in outcome #5.
Safety Investigator Assessments
时间窗: 3 months post last treatment follow up visit
Evaluate the clinical safety of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow, as assessed by study physician. The investigator would examine the patient's skin before and after treatments and on follow up visits and would be requested to fill in a physician assessment, ranking Edema, erythema, ulceration/erosion, hypopigmentation and hyperpigmentation on a 5 option scale ranging from 0. - Absent to 4. Prominent. Safety would be checked every visit.
次要结局
- Efficacy Investigator Assessments(On the second treatment visit date (pre treatment), 3 months post last treatment follow up visit)
- Subject Efficacy Assessments(On the second treatment visit date (pre treatment), 3 months post last treatment follow up visit)