Evaluating the effects of microfocused ultrasound on facial tightening

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

This study is testing if microfocused ultrasound can help tighten and rejuvenate the face over time by comparing photos of participants before and after treatment.

Quick facts

• Study type: Observational
• Enrollment: 32 (estimated)
• Ages: 25 Years to 60 Years
• Sex: Female
• Sponsor: First Affiliated Hospital of Jinan University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06286384 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the long-term effects of microfocused ultrasound on facial rejuvenation by comparing standardized photographs of participants before and after treatment. The study employs a non-randomized, evaluator-blinded design to capture changes in facial appearance at multiple time points, including immediately post-treatment and at intervals up to one year. Efficacy will be measured using a combination of photographic modeling and patient satisfaction scores, alongside a dermatological testing system to evaluate skin function.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 25 to 60 with visible signs of facial aging, such as sagging skin and wrinkles.

Not a fit: Patients with significant skin conditions, unrealistic expectations, or those who are pregnant or lactating may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a non-invasive option for patients seeking effective facial rejuvenation.

How similar studies have performed: While the use of microfocused ultrasound for facial rejuvenation is gaining interest, this specific observational approach is relatively novel and has not been extensively tested in similar studies.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong

• First Affiliated Hospital of Jinan University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Xuangu LI

Conditions Facial Aging; facial aging; Microfocused Ultrasound; Rejuvenation