Safety and Efficacy of Combining Thread Lifting With Microfocused Ultrasound for Lifting and Tightening the Face
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change in Subject Global Aesthetic Improvement Scale from baseline to 6 months, and 12 months after treatment for each side of the face.
研究概览
简要总结
Skin aging is a continuous and inevitable presses usually starting at the age of mid-twenties, this prosses affects all facial layers including skin, subcutaneous fat, superficial muscular aponeurotic system (SMAS), deep facia, the retaining ligaments, muscle activity, and even facial bony structure . The clinical outcome of this process causes the aging signs of the face and neck, including loose facial skin, sagging cheeks, excess skin hanging from the lower jawline and excess fat in the neck .
In the last decade with the introduction of absorbable threads, thread lifting has gained interest and popularity among patients and physicians, as noninvasive technique to treat ptotic skin and reposition of ptotic soft tissue into a more anatomical direction. Histopathological studies indicated that dermal and subcutaneous foreign body reaction after inserting the threads, in forms of collagen deposition, and fibrosis , could explain the tightening effect throughout contracture and remodeling. However, some studies question efficacy especially in the aspects of durability and patient satisfaction .
Another nonsurgical alternative for facial rejuvenation is high-intensity focused ultrasound (HIFU) therapy, during the past decade, HIFU has been used as a clinical noninvasive surgical tool to treat tumors, including those of the liver, prostate, and uterus (10-12) The HIFU devices heat tissue with acoustic energy in a focused, controlled manner. The thermal injury within the tissue leads to focal necrosis and cellular damage, initiating an inflammatory cascade that culminates in tissue remodeling, similar to changes that occur after ablative or nonablative laser treatments .
The Investigators hypothesis that the HIFU treatment followed immediately by thread insertion can amplify and enhance the skin fibrosis, tissue lifting capacity and might give better and longer clinical results in treating ptotic skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals.
- •Ages ≥ 30 y.o.
- •Male and female
- •Mild to moderate facial laxity and skin ptosis (Modified Fitzpatrick Wrinkle Scale class 1 and 2 )
排除标准
- •breastfeeding,
- •Immunosuppressed individual or individual taking immunosuppressive medications.
- •active systemic or local infections E) collagen vascular disease F) scaring in the planed treatment area G) History of vascular or bleeding disorders H) psychiatric illness I) inability to provide informed consent J) ablative or non-ablative skin procedures in the last 6 months K) surgical procedures within a year to the proposed treatment sites L) Excessive skin laxity on the lower face and neck
结局指标
主要结局
Change in Subject Global Aesthetic Improvement Scale from baseline to 6 months, and 12 months after treatment for each side of the face.
时间窗: 3, 6 months and 12 months after treatment
Subject Global Aesthetic Improvement Scale (SGAIS): (0 = no change; 1 = mild changes; 2 = moderate changes; 3 = significant changes)
Skin lifting in upper, mid and lower part of the face: 3, 6 months and 12 months after treatment for each side of the face
时间窗: 3, 6 months and 12 months after treatment
For assessment of skin lifting, the face will be devided into three segmnets : upper, mid, and lower third. The mid-third face-lift will be evaluated by mid-cheek angle. The lower third face-lift will be evaluated by submental lift. The mid-cheek angle will the angle between a horizontal line drawn from alae nasi and a line drawn from alae nasi to the malar prominence.
Change in Investigator Global Aesthetic Improvement Scale from baseline to 6 months, and 12 months after treatment for each side of the face
时间窗: 3, 6 months and 12 months after treatment
Investigator Global Aesthetic Improvement Scale (IGAIS) from the standardized photographs (0 = no change; 1 = mild improvement; 2 = moderate improve- ment; and 3 = significant improvement)
Wrinkle score, Texture score and pore score calculated by VISIA Software 3, 6 months and 12 months after treatment for each side of the face
时间窗: 3, 6 months
次要结局
- Occurrence of treatment-related adverse effects collected during the treatment and follow-up periods.(12 months)
- Patients pain sensation during the treatment for each side of the face at the first visit(1 month)