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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Focused Ultrasound with Dot Hand-piece | Experimental |
| |
| Focused Ultrasound With Micro-focused Hand-piece | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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. |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser Aesthetic Center, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | Beijing Municipality | 100000 | China |
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.
Beginning 6 months after study completion and ending 36 months thereafter.
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.
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This is a randomized split-face study in which each participant serves as their own control. Different focused ultrasound hand-pieces are randomly assigned to opposite sides of the face within the same participant.
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| 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. |
|
| 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 |
| 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 |