Thread Lifting and Microfocused Ultrasound for Face Tightening Ultrasound for Lifting and Tightening the Face
NCT ID: NCT04157218
Last Updated: 2019-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
45 participants
INTERVENTIONAL
2019-11-15
2021-11-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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 .
TREATMENT
NONE
Study Groups
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Treatment with HIFU and immediately after insertion of threads
HIFU device (Doublo, HIRONIC Co., Sungnam, Korea)
The areas treated with HIFU will include: The forehead, temples, and malar area, cheeks and submental area .
Threads used in this study are absorbable Aptos
The threads will be inserted to the cheeks
Treatment with HIFU and 6 months later insertion of theads
HIFU device (Doublo, HIRONIC Co., Sungnam, Korea)
The areas treated with HIFU will include: The forehead, temples, and malar area, cheeks and submental area .
Threads used in this study are absorbable Aptos
The threads will be inserted to the cheeks
Treatment with lifting threads alone
Threads used in this study are absorbable Aptos
The threads will be inserted to the cheeks
Interventions
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HIFU device (Doublo, HIRONIC Co., Sungnam, Korea)
The areas treated with HIFU will include: The forehead, temples, and malar area, cheeks and submental area .
Threads used in this study are absorbable Aptos
The threads will be inserted to the cheeks
Eligibility Criteria
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Inclusion Criteria
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
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
30 Years
60 Years
ALL
Yes
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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Locations
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Tel Aviv Meical Center
Tel Aviv, , Israel
Countries
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Facility Contacts
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Other Identifiers
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0352-19-TLV
Identifier Type: -
Identifier Source: org_study_id
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