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

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

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.

Study Overview

• Status: Unknown
• Conditions: Skin Lifting and Tightening
• Intervention / Treatment: Device: HIFU device (Doublo, HIRONIC Co., Sungnam, Korea); Device: Threads used in this study are absorbable Aptos

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 33266
    • Recruiting
    • Tel Aviv Meical Center
    • Contact: Fares Salameh, M.D.; Phone Number: 972544478868; Email: faressalameh@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy individuals.
2. Ages ≥ 30 y.o.
3. Male and female
4. Mild to moderate facial laxity and skin ptosis (Modified Fitzpatrick Wrinkle Scale class 1 and 2 )

Exclusion Criteria:

1. pregnancy
2. breastfeeding,
3. Immunosuppressed individual or individual taking immunosuppressive medications.
4. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): November 15, 2019
• Primary Completion (Anticipated): November 15, 2020
• Study Completion (Anticipated): November 15, 2021

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Actual): November 8, 2019
• Last Update Submitted That Met QC Criteria: November 6, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 0352-19-TLV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No