An interventional study of Focused UltrasoundDot Hand-piece (FUS-D) and Focused Ultrasound Micro-focused Hand-piece (FUS-M) in Facial Skin Laxity and Skin Aging, sponsored by The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College · Not applicable, Interventional, and Treatment
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:
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.
The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Focused UltrasoundDot Hand-piece (FUS-D)
Device: Focused Ultrasound Micro-focused Hand-piece (FUS-M)
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 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.
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.
Time frame: 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.
Time frame: From treatment through 6 months post-treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: From treatment through 6 months post-treatment
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.
Time frame: 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.
Time frame: 6 months post-treatment
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College