NCT04157218

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

Status unknown NA Last updated 8 November 2019

What this trial tests

NA trial testing HIFU device (Doublo, HIRONIC Co., Sungnam, Korea) in Skin Lifting and Tightening in 45 participants. Status unknown.

Timeline

15 November 2019

Primary endpoint
15 November 2020

15 November 2021

Quick facts

Lead sponsor	Tel-Aviv Sourasky Medical Center
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	15 November 2019
Primary completion	15 November 2020
Estimated completion	15 November 2021
Sites	1 location across Israel

Drugs / interventions tested

• HIFU device (Doublo, HIRONIC Co., Sungnam, Korea)
• Threads used in this study are absorbable Aptos

Conditions studied

• Skin Lifting and Tightening — all drugs for Skin Lifting and Tightening →

Sponsor

Tel-Aviv Sourasky Medical Center

Who can join

Adults 30 to 60, any sex, with Skin Lifting and Tightening. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.