Focused Ultrasound Treatment for Facial Skin Laxity

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

Status: Active, not recruiting

Conditions: Facial Skin Laxity; Skin Aging

Treatments: Device: Focused UltrasoundDot Hand-piece (FUS-D); Device: Focused Ultrasound Micro-focused Hand-piece (FUS-M)

Study type: Interventional

Funder types: Other

Identifiers

NCT07381218

PSH-CAMS-HIFU-2025

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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19 participants in 2 patient groups

Focused Ultrasound with Dot Hand-piece

Experimental group

Treatment:

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

Focused Ultrasound With Micro-focused Hand-piece

Experimental group

Treatment:

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