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Focused Ultrasound Treatment for Facial Skin Laxity

NCT07381218 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2026-04-21

No results posted yet for this study

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

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.

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-03
Primary Completion
2026-03-14
Completion
2026-03-14

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07381218 on ClinicalTrials.gov