Thread Lifting and Microfocused Ultrasound for Face Tightening Ultrasound for Lifting and Tightening the Face

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Efficacy of Combining Thread Lifting With Microfocused Ultrasound for Lifting and Tightening the Face

Conditions
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Skin Lifting and Tightening

Intervention / Treatment
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* Device: HIFU device (Doublo, HIRONIC Co., Sungnam, Korea)
* Device: Threads used in this study are absorbable Aptos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 ) Exclusion Criteria: pregnancy 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized to one of three intervention protocols using Excel 2017 (Microsoft, Redmond, WA, USA): Treatmnet with HIFU and immediately after, the insertion of lifting threads. Treatmnet with HIFU and 6 months later, the insertion of lifting threads. Treatmnet with lifting threads alone .
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment with HIFU and immediately after insertion of threads<br> | Device: HIFU device (Doublo, HIRONIC Co., Sungnam, Korea)<br>* The areas treated with HIFU will include: The forehead, temples, and malar area, cheeks and submental area .<br>Device: Threads used in this study are absorbable Aptos<br>* The threads will be inserted to the cheeks<br>|
| Active Comparator: Treatment with HIFU and 6 months later insertion of theads<br> | Device: HIFU device (Doublo, HIRONIC Co., Sungnam, Korea)<br>* The areas treated with HIFU will include: The forehead, temples, and malar area, cheeks and submental area .<br>Device: Threads used in this study are absorbable Aptos<br>* The threads will be inserted to the cheeks<br>|
| Active Comparator: Treatment with lifting threads alone<br> | Device: Threads used in this study are absorbable Aptos<br>* The threads will be inserted to the cheeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Investigator Global Aesthetic Improvement Scale from baseline to 6 months, and 12 months after treatment for each side of the face | Investigator Global Aesthetic Improvement Scale (IGAIS) from the standardized photographs (0 = no change; 1 = mild improvement; 2 = moderate improve- ment; and 3 = significant improvement) | 3, 6 months and 12 months after treatment | 
| Change in Subject Global Aesthetic Improvement Scale from baseline to 6 months, and 12 months after treatment for each side of the face. | Subject Global Aesthetic Improvement Scale (SGAIS): (0 = no change; 1 = mild changes; 2 = moderate changes; 3 = significant changes) | 3, 6 months and 12 months after treatment | 
| 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 | 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. | 3, 6 months and 12 months after treatment | 
| 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 |  | 3, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of treatment-related adverse effects collected during the treatment and follow-up periods. | including pain, nerve irritation , numbness/paresthesia , lumps , erythema, tingling, swelling , headache , rash, and pruritus | 12 months | 
| Patients pain sensation during the treatment for each side of the face at the first visit | Visual Analogue Scale (VAS) (0-10), with 0 denoting no sensation and 10 denoting the worst possible pain. | 1 month |