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

NCT06286384 | Completed DMC

• 1 other identifier: LEMU47
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 and to explore the effects of microfocused ultrasound on the function of the skin.

Conditions

Facial Aging

Keywords

facial aging; Microfocused Ultrasound; Rejuvenation

Outcome Measures

Primary Outcomes (6)

• 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;

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

• 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;

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

• 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;

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

• 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;

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

• 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;

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

• Brow Lift Height

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

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

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy women who age naturally

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Jinan University: lead

Study Sites (1)

First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

• 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.

  PMID: 40931143 DERIVED

Study Officials

• Hongwei LIU

  First Affiliated Hospital of Jinan University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Plastic Surgery Department Director

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: July 3, 2023
• Primary Completion: March 10, 2025
• Study Completion: March 15, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

CN (1)