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Completed

NCT Number: NCT07381218

Focused Ultrasound Treatment 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.

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Key information

Conditions

Facial Skin Laxity Skin Aging

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Beijing, Beijing Municipality, 100000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

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

    Time frame: Baseline to 6 months post-treatment

    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.

  2. Incidence and severity of treatment-related adverse events

    Time frame: From treatment through 6 months post-treatment

    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.

Secondary outcomes

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

    Time frame: Baseline to 6 months post-treatment

    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.

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

    Time frame: Baseline to 6 months post-treatment

    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.

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

    Time frame: From treatment through 6 months post-treatment

    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.

Other outcomes

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

    Time frame: Periprocedural

    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.

  2. Overall Participant satisfaction assessed by a 5-point Likert scale

    Time frame: 6 months post-treatment

    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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 2, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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