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Facial AgingNCT06286384

Evaluating the Long-term Effects of Microfocused Ultrasound on Facial Tightening Using Quantitative Instruments

An observational study of Facial Aging, run by First Affiliated Hospital of Jinan University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A non-randomized, evaluator-blinded study was conducted to observe the changes in the face before and after facial rejuvenation using microfocused ultrasound. The efficacy of microfocused ultrasound in facial rejuvenation was evaluated using standardized photographs in conjunction with a dermatological testing system… Read more about this study

Who is it for?
Ages 25 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Facial Aging
How many people
30 participants
Where
1 siteChina
Study dates
3 Jul 2023to 15 Mar 2025
Phase
Observational
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 25 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Healthy women who age naturally

Who may be able to join

  • Ages between 25 and 60 years old.
  • Clear manifested skin issues such as sagging and wrinkles: Merz Facial Aesthetics Score of 2 or above.
  • Absence of significant systemic diseases, cardiovascular disorders, impaired liver or kidney function, malignant tumors, etc.
  • Willing to participate in this study and sign an informed consent form.

Who cannot join

  • Pregnant or lactating women.
  • Individuals with a scar-prone constitution, allergic or abnormally healing skin.
  • Treatment areas with damaged skin, acute inflammation, active infection, rosacea, vitiligo in the progressive stage, or severe acne.
  • Patients with skin conditions such as urticaria, itching, or other dermatological diseases.
  • Those with psychological disorders or drug allergies.
  • Individuals harboring unrealistic expectations about treatment outcomes.
Show all 14Show fewer
  • Treatment areas containing metal foreign bodies or fillers deemed unsuitable for treatment by the physician.
  • Recent facial laser treatments or injections within the past month, including but not limited to filler treatments such as hyaluronic acid, botulinum toxin, and PRP injection therapy.
  • Any skin-tightening cosmetic treatments on the face or neck within the last three months.
  • Any minimally invasive cosmetic treatments on the face within the last three months.
  • Thread embedding treatments on the face within the last year, excluding thread blepharoplasty.
  • Patients with severe insomnia or those requiring intense sun exposure within the next three months.
  • Patients deemed unsuitable for participation by the investigator.
  • Those unable to cooperate with the treatment and complete all required visits.

Trial locations and contacts

1 site in 1 country.

China1 site

  • First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: Evaluating the Long-term Effects of Microfocused Ultrasound on Facial Tightening Using Quantitative Instruments: Efficacy and Safety

A non-randomized, evaluator-blinded study was conducted to observe the changes in the face before and after facial rejuvenation using microfocused ultrasound. The efficacy of microfocused ultrasound in facial rejuvenation was evaluated using standardized photographs in conjunction with a dermatological testing system and to explore the effects of microfocused ultrasound on the function of the skin.

Read the detailed description

Primary efficacy endpoints:Utilizing the 3D Life Viz mini system for standardized photo modeling enables the comparison and identification of enhancements in treatment outcomes. This research utilized standardized photo modeling to record the facial and mandibular conditions of patients, capturing images both before and after treatment (immediately post-operation and at 7, 30, 90, 180，270 and 360 days). The detection of improvements in treatment effects was then achieved through pairwise comparisons of the modeled data derived from these photographs;Secondary efficacy endpoints: Global Aesthetic Improvement Scale, patient satisfaction scores, Digital Visual Analog Scale

Conditions
Facial Aging
Keywords
facial aging, Microfocused Ultrasound, Rejuvenation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Volume Change of Nasolabial Folds

    Utilizing the 3D Life Viz mini system for capturing images both before and after treatment by 30、90、180 days;

    Measured: before therapy, immediately post-therapy (within 30 minutes), 7 , 30, 90, 180 ,270,and360days

  2. Change in Maximum Depth of Nasolabial Folds

    Utilizing the 3D Life Viz mini system for capturing images both before and after treatment by 30、90、180 days;

    Measured: before therapy, immediately post-therapy (within 30 minutes), 7 , 30, 90, 180 ,270,and360days

  3. Vertical Elevation Value of Nasolabial Fold Curve Projection Curve

    Utilizing the 3D Life Viz mini system for capturing images both before and after treatment by 30、90、180 days;

    Measured: before therapy, immediately post-therapy (within 30 minutes), 7 , 30, 90, 180 ,270,and360days

  4. Elevation Value of Nasolabial Fold Curve Projection Curve (Along the Nasal Wing Method

    Utilizing the 3D Life Viz mini system for capturing images both before and after treatment by 30、90、180 days;

    Measured: before therapy, immediately post-therapy (within 30 minutes), 7 , 30, 90, 180 ,270,and360days

  5. Change in Mid-Facial Volume

    Utilizing the 3D Life Viz mini system for capturing images both before and after treatment by 30、90、180 days;

    Measured: before therapy, immediately post-therapy (within 30 minutes), 7 , 30, 90, 180 ,270,and360days

  6. Brow Lift Height

    Utilizing the 3D Life Viz mini system for capturing images both before and after treatment by 30、90、180 days;

    Measured: before therapy, immediately post-therapy (within 30 minutes), 7 , 30, 90, 180 ,270,and360days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Feb 2024
  2. Study start3 Jul 2023
  3. Primary completion10 Mar 2025
  4. Study completion15 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06286384
Sponsor's protocol ID
LEMU47
Status last verified
Dec 2025
First submitted
22 Feb 2024
Last updated
30 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li X, Xie G, Yang Z, Li S, Liao X, Lu J, Jiang X, Li K, Xie S, Zhang Z, Xiao L, Huang H, Mao H, Qiao J, Zheng J, Liu H. Evaluating the Long-term Effects of Microfocused Ultrasound on Facial Tightening Using Quantitative Instruments: Efficacy and Safety. Aesthetic Plast Surg. 2026 Jan;50(2):692-706. doi: 10.1007/s00266-025-05205-z. Epub 2025 Sep 10.

    PubMed 40931143

Questions about this trial

What is this clinical trial studying?

An observational study of Facial Aging, run by First Affiliated Hospital of Jinan University 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?

The sponsor lists 4 inclusion and 14 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: finished, as of the sponsor's last update on 30 Dec 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Total Volume Change of Nasolabial Folds (time frame: before therapy, immediately post-therapy (within 30 minutes), 7 , 30, 90, 180 ,270,and360days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06286384, which also lists 1 linked publication.

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 30 Dec 2025.

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