NCT07381218

Focused Ultrasound Treatment for Facial Skin Laxity

A Prospective, Randomized, and Split-Face Study to Evaluate the Efficacy and Safety of Focused Ultrasound for Facial Skin Laxity

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Facial Skin Laxity
• Skin Aging

Interventions

Type	Name	Description
DEVICE	Focused UltrasoundDot Hand-piece (FUS-D)	Focused ultrasound treatment delivered using the dot hand-piece (FUS-D), applied to the contra lateral side of the face during a single treatment session. Treatment parameters follow the predefined study protocol.
DEVICE	Focused Ultrasound Micro-focused Hand-piece (FUS-M)	Focused ultrasound treatment delivered using the micro-focused hand-piece (FUS-M), applied to one side of the face during a single treatment session. Treatment parameters follow the predefined study protocol.

Timeline

• Start date: 2025-07-03
• Primary completion: 2026-03-14
• Completion: 2026-03-14
• First posted: 2026-02-02
• Last updated: 2026-03-03

Locations

1 site across 1 country: China