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

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.

Study Overview

• Status: Completed
• Conditions: Skin Aging; Facial Skin Laxity
• Intervention / Treatment: Device: Focused UltrasoundDot Hand-piece (FUS-D); Device: Focused Ultrasound Micro-focused Hand-piece (FUS-M)

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100000
      • Laser Aesthetic Center, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Focused Ultrasound with Dot Hand-piece	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.
Experimental: Focused Ultrasound With Micro-focused Hand-piece	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facial skin laxity assessed by VISIA skin analysis system for bilateral facial sides	Differences in facial skin laxity between the two facial sides treated with different focused ultrasound hand-pieces will be evaluated 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. A randomized split-face comparison within the same participant will be performed.	Baseline to 6 months post-treatment
Merz Aesthetic Scale (MAS) score assessed by independent blinded evaluators	Facial laxity will be assessed using the Merz Aesthetic Scale (MAS) based on standardized digital facial photographs. The MAS is a validated 5-point ordinal scale ranging from 0 to 4, with higher scores indicating greater facial laxity. MAS scores will be assessed by independent blinded evaluators at baseline, immediately after treatment, and at 1, 3, and 6 months post-treatment. A randomized split-face comparison within the same participant will be performed.	Baseline to 6 months post-treatment
Global Aesthetic Improvement Scale (GAIS) score assessed by independent blinded evaluators	Overall aesthetic improvement will be assessed using the Global Aesthetic Improvement Scale (GAIS) based on standardized digital facial photographs. GAIS is a 5-point ordinal scale (Grade 1=Exceptional improvement; Grade 2=Moderate improvement; Grade 3=Slight improvement; Grade 4=No change; Grade 5=Worsening of the condition). Lower scores indicate better aesthetic improvement. GAIS scores will be measured by both participants and independent blinded evaluators immediately post-treatment, and at 1, 3, and 6 months post-treatment. A randomized split-face comparison within the same participant will be performed.	From treatment through 6 months post-treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity score assessed by the Visual Analog Scale (VAS) for bilateral facial sides	Pain intensity associated with focused ultrasound treatment will be assessed using the Visual Analog Scale (VAS). VAS is a numeric rating scale ranging from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity. A randomized split-face comparison within the same participant will be performed.	Periprocedural
Overall Participant satisfaction assessed by a 5-point Likert scale	Participant satisfaction with treatment outcomes will be assessed at 6 months post-treatment using a 5-point Likert scale. Participants will rate their agreement with statements regarding overall treatment outcomes on a scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate greater satisfaction.	6 months post-treatment

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2025
• Primary Completion (Actual): March 14, 2026
• Study Completion (Actual): March 14, 2026

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: January 25, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 19, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Skin aging; Focused ultrasound; High-intensity focused ultrasound; Facial skin laxity; Split-face study
• Other Study ID Numbers: PSH-CAMS-HIFU-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data will be shared upon reasonable request, subject to approval by the ethics committee and the study team, and after signing a data use agreement.
• IPD Sharing Time Frame: Beginning 6 months after study completion and ending 36 months thereafter.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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