Skin Lifting and TighteningNCT04157218
Thread Lifting and Microfocused Ultrasound for Face Tightening Ultrasound for Lifting and Tightening the Face
A study testing HIFU device (Doublo, HIRONIC Co., Sungnam, Korea) and Threads used in this study are absorbable Aptos in people with Skin Lifting and Tightening, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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 . Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Lifting and Tightening
- What is being tested?
- HIFU device (Doublo, HIRONIC Co., Sungnam, Korea) and Threads used in this study are absorbable Aptos
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Nov 2019to 15 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 )
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Meical Center
Tel Aviv, 33266
Fares Salameh, M.D., 972544478868, faressalameh@hotmail.com
About this study
Official title: 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 .
Read more
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
- Being tested
- HIFU device (Doublo, HIRONIC Co., Sungnam, Korea), Threads used in this study are absorbable Aptos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 .
Threads used in this study are absorbable AptosDevice
The threads will be inserted to the cheeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment with HIFU and immediately after insertion of threads | Active comparator | Not described Receives: 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 | Not described Receives: Device: HIFU device (Doublo, HIRONIC Co., Sungnam, Korea); Device: Threads used in this study are absorbable Aptos |
| Treatment with lifting threads alone | Active comparator | Not described Receives: Device: Threads used in this study are absorbable Aptos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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.
Measured: 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
Measured: 3, 6 months
Secondary outcomes (2)
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
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start15 Nov 2019 (estimated)
- Primary completion15 Nov 2020 (estimated)
- Study completion15 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Lifting and TighteningStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 .
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157218
- Sponsor's protocol ID
- 0352-19-TLV
- Status last verified
- Oct 2019
- First submitted
- 16 Oct 2019
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Combining Thread Lifting With Microfocused Ultrasound for Lifting and Tightening the Face
- ClinicalTrials.gov ID
- NCT04157218
- Acronym / sponsor ID
- 0352-19-TLV
- Conditions
- Skin Lifting and Tightening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 15 Nov 2019 (estimated)
- Primary completion
- 15 Nov 2020 (estimated)
- Study completion
- 15 Nov 2021 (estimated)
- First posted
- 8 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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 .
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 )
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | 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 AptosThe threads will be inserted to the cheeks | Device | Treatment with HIFU and 6 months later insertion of theads, Treatment with HIFU and immediately after insertion of threads, Treatment with lifting threads alone |
Primary outcome
Change in Investigator Global Aesthetic Improvement Scale from baseline to 6 months, and 12 months after treatment for each side of the face
Time frame: 3, 6 months and 12 months after treatment
Investigator Global Aesthetic Improvement Scale (IGAIS) from the standardized photographs (0 = no change; 1 = mild improvement; 2 = moderate improve- ment; and 3 = significant improvement)
Change in Subject Global Aesthetic Improvement Scale from baseline to 6 months, and 12 months after treatment for each side of the face.
Time frame: 3, 6 months and 12 months after treatment
Subject Global Aesthetic Improvement Scale (SGAIS): (0 = no change; 1 = mild changes; 2 = moderate changes; 3 = significant changes)
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
Time frame: 3, 6 months and 12 months after treatment
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.
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
Time frame: 3, 6 months
2 secondary outcomes
Occurrence of treatment-related adverse effects collected during the treatment and follow-up periods.
Time frame: 12 months
Patients pain sensation during the treatment for each side of the face at the first visit
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIFU device (Doublo, HIRONIC Co., Sungnam, Korea) and Threads used in this study are absorbable Aptos in people with Skin Lifting and Tightening, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Investigator Global Aesthetic Improvement Scale from baseline to 6 months, and 12 months after treatment for each side of the face (time frame: 3, 6 months and 12 months after treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2019.