NCT06104514已完成不适用
Safety and Efficacy of Sofwave Treatment to Lift the Upper Lip and Improve the Peri-Oral Rhytids
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Rate of improvement in the appearance of upper lip and peri-oral rhytids
研究概览
简要总结
Open-label, non-randomized, prospective, multi-center, self-controlled
详细描述
Patients will receive 2 monthly treatments with the SofWave system and will be followed up twice: at 4 weeks and 12 weeks after last treatment (FU1-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-
- •Desire to improve the peri-oral appearance, decrease the distance between the nose and the upper lip (Philtral column length) and/or reduce the peri-oral rhytids.
- •Philtral column height>15mm or/and has moderate severe perioral rhytids.
- •Subject agrees to maintain a stable weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine during the study.
- •Able and willing to comply with all visits, treatments and evaluation schedules and requirements.
- •Able to understand and provide written Informed Consent.
- •Willing to have photographs of the treated areas. Agree for de-identified study images to be used in evaluations, publications and presentations.
- •Agree not to undergo any other facial treatments for a period of 3 months following SofWave treatments.
- •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.
- •Current smoker or has history of heavy smoking (25 cigarettes per day or more) in past 10 years.
- •Melanoma active malignancy or history of malignancy in the past 5 years.
- •Any other non-melanoma malignancy active malignancy or history of malignancy in the past 5 years within the intended to treat area.
- •Previous chemotherapy treatments.
- •Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders (i.e. any disease state that in the opinion of the investigator may interfere with the anesthesia, treatment, or healing process).
- •History of chronic drug or alcohol abuse
- •History of Epileptic seizures.
- •History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
- •Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen.
- •History of significant lymphatic drainage problems within the facial areas.
- •History of epidermal or dermal disorders (particularly involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders.
- •Excessive subcutaneous fat on the face.
- •Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-coagulant within the past 2 weeks
- •Currently taking or has taken diet pills or weight control supplements within the past month.
- •Non-stable weight ( ±5%) within the past month.
- •Medical disorder that may hinder the wound healing or immune response (such as blood disorder, inflammatory disease, etc.)
- •Known allergy to Lidocaine, Tetracaine, Xylocaine, Epinephrine or antibiotics.
- •Skin disorders (skin systematic or local infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area.
- •Severe solar elastosis at the intended to treat area.
- •Tattoo or former tattoo at or near treatment area.
- •Tendency for Melasma inflammation.
- •Significant scarring, atrophic scars in the area to be treated, or has a history of atrophic scars or keloids or prone to bruising.
- •Surgical or traumatic scar in the intended to treat area.
- •Presence of a metal stent or implant in the facial area (e.g. braces; dental implants are not excluded).
- •History of cosmetic treatments in the facial area to be treated, including blepharoplasty, direct specific forehead lift and facial skin-tightening procedure within the 6 months;injectable (Botox or fillers) of any type within the 12 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 or neck lift within the past 12 months.
- •Currently enrolled in a clinical study of any other unapproved investigational drug or device.
- •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
Lift the upper lip and improve the peri-oral rhytids
Experimental
干预措施: Sofwave (Device)
结局指标
主要结局
Rate of improvement in the appearance of upper lip and peri-oral rhytids
时间窗: 12 weeks post last treatment
Study will be considered a success if more than 50% of the subjects will have an improvement according to investigators' assessments of pre- and post Treatment 2D images
次要结局
未报告次要终点
研究者
研究点 (6)
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