Focused Ultrasound Treatment for Facial Skin Laxity

NCT07381218 | Completed

• 1 other identifier: PSH-CAMS-HIFU-2025
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does focused ultrasound treatment lead to clinically meaningful improvement in facial skin laxity compared with baseline assessments?
2. 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.

Conditions

Facial Skin Laxity; Skin Aging

Keywords

Focused ultrasound; High-intensity focused ultrasound; Facial skin laxity; Skin aging; Randomized controlled trial; Split-face study

Outcome Measures

Primary Outcomes (2)

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

  Facial skin laxity will be quantitatively assessed using the VISIA skin analysis system. Skin laxity-related parameters will be measured at baseline, immediately post-treatment, and at 1,3, and 6 months post-treatment. Higher values indicate greater skin laxity. The change from baseline at each follow-up time point will be analyzed.

  Baseline to 6 months post-treatment

• Incidence and severity of treatment-related adverse events

  Treatment-related adverse events will be recorded and evaluated throughout the study, including the type, frequency, and severity of adverse events following focused ultrasound treatment.

  From treatment through 6 months post-treatment

Secondary Outcomes (3)

• Facial skin laxity assessed by VISIA skin analysis system for bilateral facial sides

  Baseline to 6 months post-treatment

• Merz Aesthetic Scale (MAS) score assessed by independent blinded evaluators

  Baseline to 6 months post-treatment

• Global Aesthetic Improvement Scale (GAIS) score assessed by independent blinded evaluators

  From treatment through 6 months post-treatment

Other Outcomes (2)

• Pain intensity score assessed by the Visual Analog Scale (VAS) for bilateral facial sides

  Periprocedural

• Overall Participant satisfaction assessed by a 5-point Likert scale

  6 months post-treatment

Study Arms (2)

Focused Ultrasound with Dot Hand-piece

EXPERIMENTAL

Device: Focused UltrasoundDot Hand-piece (FUS-D)

Focused Ultrasound With Micro-focused Hand-piece

EXPERIMENTAL

Device: Focused Ultrasound Micro-focused Hand-piece (FUS-M)

Interventions

Focused UltrasoundDot Hand-piece (FUS-D) DEVICE

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.

Focused Ultrasound with Dot Hand-piece

Focused Ultrasound Micro-focused Hand-piece (FUS-M) DEVICE

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.

Focused Ultrasound With Micro-focused Hand-piece

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College: lead

Study Sites (1)

Laser Aesthetic Center, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: This is a randomized split-face study in which each participant serves as their own control. Different focused ultrasound hand-pieces are randomly assigned to opposite sides of the face within the same participant.

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: February 2, 2026
• Study Start: July 3, 2025
• Primary Completion: March 14, 2026
• Study Completion: March 14, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after study completion and ending 36 months thereafter.
• Access Criteria: Data will be shared upon reasonable request, subject to approval by the study team and ethics committee, and after execution of a data use agreement.

Locations

CN (1)