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

NCT04157218 | Unknown DMC

• 1 other identifier: 0352-19-TLV
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Lifting and Tightening

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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

Study Arms (3)

Treatment with HIFU and immediately after insertion of threads

ACTIVE COMPARATOR

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

Treatment with HIFU and 6 months later insertion of theads

ACTIVE COMPARATOR

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

Treatment with lifting threads alone

ACTIVE COMPARATOR

Device: Threads used in this study are absorbable Aptos

Interventions

HIFU device (Doublo, HIRONIC Co., Sungnam, Korea) DEVICE

The areas treated with HIFU will include: The forehead, temples, and malar area, cheeks and submental area .

Treatment with HIFU and 6 months later insertion of theads; Treatment with HIFU and immediately after insertion of threads

Threads used in this study are absorbable Aptos DEVICE

The threads will be inserted to the cheeks

Treatment with HIFU and 6 months later insertion of theads; Treatment with HIFU and immediately after insertion of threads; Treatment with lifting threads alone

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 )

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Meical Center

Tel Aviv, 33266, Israel

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to one of three intervention protocols using Excel 2017 (Microsoft, Redmond, WA, USA): 1. Treatmnet with HIFU and immediately after, the insertion of lifting threads. 2. Treatmnet with HIFU and 6 months later, the insertion of lifting threads. 3. Treatmnet with lifting threads alone .

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: November 8, 2019
• Study Start: November 15, 2019
• Primary Completion: November 15, 2020
• Study Completion: November 15, 2021
• Last Updated: November 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)