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

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

By utilizing standardized photographs in conjunction with quantification detection instruments, data analysis before and after treatment is conducted, along with long-term efficacy observations. This approach aims to provide more comprehensive scientific evidence for the clinical application of ultrasound treatment in anti-aging therapy.

Study Overview

• Status: Recruiting
• Conditions: Facial Aging

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, and 180 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

• Study Type: Observational
• Enrollment (Estimated): 32

Contacts and Locations

• Study Contact: Name: Xuangu LI; Phone Number: 13825136477; Email: 443747565@qq.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • First Affiliated Hospital of Jinan University
      • Contact: Xuangu LI; Phone Number: +8613825136477; Email: 443747565@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy women who age naturally

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Pregnant or lactating women.
2. Individuals with a scar-prone constitution, allergic or abnormally healing skin.
3. Treatment areas with damaged skin, acute inflammation, active infection, rosacea, vitiligo in the progressive stage, or severe acne.
4. Patients with skin conditions such as urticaria, itching, or other dermatological diseases.
5. Those with psychological disorders or drug allergies.
6. Individuals harboring unrealistic expectations about treatment outcomes.
7. Treatment areas containing metal foreign bodies or fillers deemed unsuitable for treatment by the physician.
8. 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.
9. Any skin-tightening cosmetic treatments on the face or neck within the last three months.
10. Any minimally invasive cosmetic treatments on the face within the last three months.
11. Thread embedding treatments on the face within the last year, excluding thread blepharoplasty.
12. Patients with severe insomnia or those requiring intense sun exposure within the next three months.
13. Patients deemed unsuitable for participation by the investigator.
14. Those unable to cooperate with the treatment and complete all required visits.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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;	30、90、180 days
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;	30、90、180 days
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;	30、90、180 days
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;	30、90、180 days
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;	30、90、180 days
Brow Lift Height	Utilizing the 3D Life Viz mini system for capturing images both before and after treatment by 30、90、180 days;	30、90、180 days

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Jinan University
• Investigators: Study Chair: Hongwei LIU, First Affiliated Hospital of Jinan University

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2023
• Primary Completion (Estimated): September 15, 2024
• Study Completion (Estimated): March 15, 2025

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Estimated): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Rejuvenation; facial aging; Microfocused Ultrasound
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Facies
• Other Study ID Numbers: LEMU47

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No