CompletedNot Applicable

Focused Ultrasound Treatment for Facial Skin Laxity

China19 participantsStarted 2025-07-03

Plain-language summary

The goal of this clinical trial is to learn if focused ultrasound can improve facial skin laxity in adults. The main questions this study aims to answer are: 1. Does focused ultrasound treatment lead to clinically meaningful improvement in facial skin laxity compared with baseline assessments? 2. What treatment-related adverse events occur following focused ultrasound treatment, and how frequently and severely do they occur? Researchers will also compare outcomes between the two sides of the face treated with different focused ultrasound hand-pieces within the same participants to explore potential differences in clinical response and safety using a randomized split-face design. Participants will: Receive a single session of focused ultrasound treatment applied to both sides of the face. Undergo standardized clinical assessments, imaging evaluations, and patient-reported outcome measures at baseline and during follow-up visits. Be monitored for treatment-related adverse events throughout the study period.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults aged 18 years or older * Male or female participants * Presence of mild to moderate facial skin laxity * Willingness to undergo focused ultrasound treatment of the face * Ability to understand the study procedures and provide written informed consent * Willingness to comply with study visits and follow-up assessments Exclusion Criteria: * Pregnancy or breastfeeding * Severe systemic diseases, including but not limited to significant cardiac, hepatic, renal, or neurological disorders * Active skin infection, inflammation, or open wounds in the treatment area * History of facial cosmetic procedures (including laser treatment, injectable fillers, or energy-based devices) within the past 6 months * Presence of implanted electronic devices or metallic implants in the facial area * Known hypersensitivity or contraindications to focused ultrasound treatment * Any condition that, in the investigator's judgment, would make the participant unsuitable for study participation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in facial skin laxity from baseline assessed by VISIA skin analysis system

Timeframe: Baseline to 6 months post-treatment

Incidence and severity of treatment-related adverse events

Timeframe: From treatment through 6 months post-treatment

Trial details

NCT IDNCT07381218

SponsorThe Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-14

View on ClinicalTrials.gov More Facial Skin Laxity trials