Facial Skin LaxityNCT07381218
Focused Ultrasound Treatment for Facial Skin Laxity
A study testing Focused UltrasoundDot Hand-piece (FUS-D) and Focused Ultrasound Micro-focused Hand-piece (FUS-M) in people with Facial Skin Laxity and Skin Aging, run by The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Skin Laxity, Skin Aging
- What is being tested?
- Focused UltrasoundDot Hand-piece (FUS-D) and Focused Ultrasound Micro-focused Hand-piece (FUS-M)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2025to 14 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Laser Aesthetic Center, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100000
About this study
Official title: A Prospective, Randomized, and Split-Face Study to Evaluate the Efficacy and Safety of Focused Ultrasound 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:
- Does focused ultrasound treatment lead to clinically meaningful improvement in facial skin laxity compared with baseline assessments?
- 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.
Read more
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
- Being tested
- Focused UltrasoundDot Hand-piece (FUS-D), Focused Ultrasound Micro-focused Hand-piece (FUS-M)
- Keywords
- Focused ultrasound, High-intensity focused ultrasound, Facial skin laxity, Skin aging, Randomized controlled trial, Split-face study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Focused Ultrasound with Dot Hand-piece | Experimental | Not described Receives: Device: Focused UltrasoundDot Hand-piece (FUS-D) |
| Focused Ultrasound With Micro-focused Hand-piece | Experimental | Not described Receives: Device: Focused Ultrasound Micro-focused Hand-piece (FUS-M) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From treatment through 6 months post-treatment
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: From treatment through 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start3 Jul 2025
- Primary completion14 Mar 2026
- Study completion14 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial Skin LaxityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang Lvping, The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381218
- Sponsor's protocol ID
- PSH-CAMS-HIFU-2025
- Status last verified
- Apr 2026
- First submitted
- 13 Jan 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, and Split-Face Study to Evaluate the Efficacy and Safety of Focused Ultrasound for Facial Skin Laxity
- ClinicalTrials.gov ID
- NCT07381218
- Acronym / sponsor ID
- PSH-CAMS-HIFU-2025
- Conditions
- Facial Skin Laxity, Skin Aging
- Keywords
- Focused ultrasound, High-intensity focused ultrasound, Facial skin laxity, Skin aging, Randomized controlled trial, Split-face study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeUniversity, hospital or other
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- 14 Mar 2026 (actual)
- Study completion
- 14 Mar 2026 (actual)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does focused ultrasound treatment lead to clinically meaningful improvement in facial skin laxity compared with baseline assessments?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Focused Ultrasound with Dot Hand-piece | Experimental | Device: Focused UltrasoundDot Hand-piece (FUS-D) |
| Focused Ultrasound With Micro-focused Hand-piece | Experimental | Device: Focused Ultrasound Micro-focused Hand-piece (FUS-M) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 with Dot Hand-piece |
| 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. | Device | Focused Ultrasound With Micro-focused Hand-piece |
Primary outcome
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.
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.
3 secondary outcomes
Facial skin laxity assessed by VISIA skin analysis system for bilateral facial sides
Time frame: Baseline to 6 months post-treatment
Merz Aesthetic Scale (MAS) score assessed by independent blinded evaluators
Time frame: Baseline to 6 months post-treatment
Global Aesthetic Improvement Scale (GAIS) score assessed by independent blinded evaluators
Time frame: From treatment through 6 months post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused UltrasoundDot Hand-piece (FUS-D) and Focused Ultrasound Micro-focused Hand-piece (FUS-M) in people with Facial Skin Laxity and Skin Aging, run by The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in facial skin laxity from baseline assessed by VISIA skin analysis system (time frame: Baseline to 6 months post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.