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

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Skin Lifting and Tightening

Treatments: Device: Threads used in this study are absorbable Aptos; Device: HIFU device (Doublo, HIRONIC Co., Sungnam, Korea)

Study type: Interventional

Funder types: Other

Identifiers

NCT04157218

0352-19-TLV

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Treatment with HIFU and immediately after insertion of threads

Active Comparator group

Treatment:

Device: Threads used in this study are absorbable Aptos

Device: HIFU device (Doublo, HIRONIC Co., Sungnam, Korea)

Treatment with HIFU and 6 months later insertion of theads

Active Comparator group

Treatment:

Device: Threads used in this study are absorbable Aptos

Device: HIFU device (Doublo, HIRONIC Co., Sungnam, Korea)

Treatment with lifting threads alone

Active Comparator group

Treatment:

Device: Threads used in this study are absorbable Aptos