Middle and Lower Face and Submental Region Skin LaxityNCT06449911
The Efficacy of Microfocused Ultrasound Technique in the Treatment of Facial Skin Laxity
A study testing HIFU in people with Middle and Lower Face and Submental Region Skin Laxity, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This is a prospective study of 20 Chinese patients with lower facial laxity treated by High Intense focused ultrasound (HIFU). Response will be assessed via paired comparison of pretreatment and posttreatment photographs by two independent dermatologists, grading on a 5-point Subject Global Aesthetic Improvement Scale… Read more about this study
- Who is it for?
- Ages 30 to 59 years
- Conditions the study is for
- Middle and Lower Face and Submental Region Skin Laxity
- What is being tested?
- HIFU
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to Jul 2024
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria: healthy male or female, aged 30-60 years, seeking improved jawline definition, and/or reduction of submental skin laxity and were willing and able to provide informed consent.
Exclusion Criteria: Pregnancy or lactation, severe sun damage, excessive skin laxity on the lower face and neck, keloid scarring or open wounds in the treatment areas, severe or cystic facial acne, history of cosmetic treatments in the area to be treated (skin tightening procedure within the past year; injectable filler or botox within the past 6 months; ablative or nonablative resurfacing/rejuvenating laser treatment or light treatment within the past 6 months; dermabrasion or deep facial peels within the past 6 months), isotretinoin treatment within the past 6 months, and inability to understand the treatment protocol or to give informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Dermatology, Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
About this study
Official title: Efficacy and Safety of High Intense Focused Ultrasound for Treating Middle and Lower Face and Submental Region Laxity
This is a prospective study of 20 Chinese patients with lower facial laxity treated by High Intense focused ultrasound (HIFU). Response will be assessed via paired comparison of pretreatment and posttreatment photographs by two independent dermatologists, grading on a 5-point Subject Global Aesthetic Improvement Scale (SGAIS) for skin laxity. Quantitative analysis of submental lifting will also be performed. Patient's level of "sagging" and "volume loss", satisfaction and tolerance will be documented.
- Being tested
- HIFU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFUProcedure or surgery
300 lines and 10,200 dots will be performed to each half lower two-thirds of the face and submental area of every participant.
| Study group | Role | What they receive |
|---|---|---|
| HIFU | Experimental | All participants will be treated using M4.5, level V, with 150 lines on the lower face and submental area; D4.5, level V, 10 Hz, with 4200 dots performed in 7 min on the lower face and the perioral and preauricular areas; M3.0, level V, with 150 lines on the lower face and submental area; D3.0, level V, 10 Hz, with 6000 dots performed in 10 min on the lower face, submental area, and middle face. The microfocused probes were uniformly set to a length of 25 mm with an interval of 1.5 mm. A total of 300 lines and 10,200 dots were performed for each half lower two-thirds of the face and submental area. Receives: Procedure: HIFU |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-point Subject Global Aesthetic Improvement Scale (SGAIS) for skin laxity
0-worse, 1-0%-25% poor response, 2-25%-50% fair response, 3-50%-75% good response, 4-75%-100%-excellent response.
Measured: 6 months after HIFU treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 Feb 2023
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Middle and Lower Face and Submental Region Skin LaxityStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449911
- Sponsor's protocol ID
- 2022-0919
- Status last verified
- Dec 2023
- First submitted
- 4 Jun 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of High Intense Focused Ultrasound for Treating Middle and Lower Face and Submental Region Laxity
- ClinicalTrials.gov ID
- NCT06449911
- Acronym / sponsor ID
- 2022-0919
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 10 Jun 2024 (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.
This is a prospective study of 20 Chinese patients with lower facial laxity treated by High Intense focused ultrasound (HIFU). Response will be assessed via paired comparison of pretreatment and posttreatment photographs by two independent dermatologists, grading on a 5-point Subject Global Aesthetic Improvement Scale (SGAIS) for skin laxity. Quantitative analysis of submental lifting will also be performed. Patient's level of "sagging" and "volume loss", satisfaction and tolerance will be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIFU | Experimental | Procedure: HIFUAll participants will be treated using M4.5, level V, with 150 lines on the lower face and submental area; D4.5, level V, 10 Hz, with 4200 dots performed in 7 min on the lower face and the perioral and preauricular areas; M3.0, level V, with 150 lines on the lower face and submental area; D3.0, level V, 10 Hz, with 6000 dots performed in 10 min on the lower face, submental area, and middle face. The microfocused probes were uniformly set to a length of 25 mm with an interval of 1.5 mm. A total of 300 lines and 10,200 dots were performed for each half lower two-thirds of the face and submental area. |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| HIFU300 lines and 10,200 dots will be performed to each half lower two-thirds of the face and submental area of every participant. | Procedure or surgery | HIFU |
Primary outcome
5-point Subject Global Aesthetic Improvement Scale (SGAIS) for skin laxity
Time frame: 6 months after HIFU treatment
0-worse, 1-0%-25% poor response, 2-25%-50% fair response, 3-50%-75% good response, 4-75%-100%-excellent response.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Middle and Lower Face and Submental Region Skin Laxity, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 10 Jun 2024. 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 China. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-point Subject Global Aesthetic Improvement Scale (SGAIS) for skin laxity (time frame: 6 months after HIFU treatment). 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 10 Jun 2024.