Facial Skin LaxityNCT07890987
VISION Study: Visualization-Guided SMAS Treatment to Optimize Nonsurgical Lifting
A study testing Microfocused Ultrasound with Visualization (MFU-V) and multi Microfocused Ultrasound with Visualization (MFU-V) in people with Facial Skin Laxity, run by Ocean Clinic at 1 site in Spain.
Trial summary
The VISION study is a prospective, randomized, single-center, split-face Phase IV clinical trial evaluating whether customized multi-depth microfocused ultrasound with visualization (Ultherapy PRIME) targeting the SMAS/fibromuscular layer provides superior tissue firmness and lifting compared with single-depth dermal… Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Skin Laxity
- What is being tested?
- Microfocused Ultrasound with Visualization (MFU-V) and multi Microfocused Ultrasound with Visualization (MFU-V)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 24 Jul 2026to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 35-80 years. SMAS/fibromuscular layer depth ≥3.0 mm. Able to provide informed consent. Willing to comply with study procedures. Likely to complete follow-up. Is willing to refrain from all non-study procedures in the face (e.g., dermal filler treatments, ablative or fractional laser, micro dermabrasion, micro needling, chemical peels, non-invasive skin tightening and/or surgical procedures, skin-irritating preparations, etc.) during participation in this investigation.
Who cannot join
- • Current GLP-1 RA use.
- Any previous surgery, including plastic surgery or permanent surgical implant, injectable permanent filler, or fat grafting in the facial area
- Any previous treatment in the facial area over the past year including: biostimulatory products, fillers (temporary/long term), laser, microdermabrasion, micro needling chemical peels, or non-invasive skin tightening treatments (electromagnetic/radio frequency/ultrasound etc.)
- Planning to receive treatment of any kind in the face during the study including: biostimulatory products not given as part of the study, fillers (temporary/long term/permanent), laser, microdermabrasion, micro needling chemical peels, non-invasive skin tightening ((electromagnetic/radio frequency/ultrasound etc.), or fat injections
- Acute inflammatory process (e.g., folliculitis) or history of chronic or recurrent infection or inflammation with the potential to interfere with the investigational results or increase the risk of AEs
- Previous application of over the counter or prescription, oral or topical, anti-wrinkle or skin enhancer products on the facial skin within the past 3 months. Use of continued therapy with some cosmeceuticals (i.e., alpha hydroxyl acids, glycolic acids) in the facial area is allowed if the regimen was established and is stable over the last >3 months. In cases of an established regimen of mentioned products at baseline, application should be consistently continued throughout the study. This excludes skin bleaching agents, retinol, and/or retinoic acids
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- Currently pregnant, breastfeeding, or intending to become pregnant during study participation
- Any contraindication to treatment with energy-based ultrasound
- Known hypersensitivity to MFU-V
- Currently using anticoagulation therapy
- History of bleeding disorders
- Any medical condition that may put the participant at increased risk with exposure to biostimulatory products
- Any medication that might modulate the immune response (steroids, biologics etc.)
- Any other illness or condition that, in the opinion of the investigator, would mean that study participation was not in the best interest of the prospective participant
- Is a female of childbearing potential and not using medically effective birth control or is pregnant or lactating (Note: Urine pregnancy tests will be used in female subjects of childbearing potential.)
- Any serious disease or disorder (medical or psychiatric) that could, in the opinion of the investigator, interfere with the safe completion of treatment according to this protocol or with study outcome assessments, or compromise subject safety (i.e., increase the risk of AEs)
- Diagnosis of Diabetes mellitus Type I or II
- Vegan diet1
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Ocean Clinic
Marbella, Malaga, 29601
Vanessa Garcia, +34 951 775 518, admon@oceanclinic.net
Kai O Kaye
About this study
Official title: Visualization-Guided SMAS Treatment to Optimize Nonsurgical Lifting (VISION): A Prospective, Single-Center, Randomized, Split-Face Phase IV Clinical Trial
The VISION study is a prospective, randomized, single-center, split-face Phase IV clinical trial evaluating whether customized multi-depth microfocused ultrasound with visualization (Ultherapy PRIME) targeting the SMAS/fibromuscular layer provides superior tissue firmness and lifting compared with single-depth dermal treatment. Fifty adults with moderate-to-severe facial skin laxity will receive different treatments on each side of the face. The primary outcome is the change in SMAS/fibromuscular layer stiffness measured by shear-wave elastography at Day 180.
- Conditions
- Facial Skin Laxity
- Being tested
- Microfocused Ultrasound with Visualization (MFU-V), multi Microfocused Ultrasound with Visualization (MFU-V)
- Keywords
- Facial Skin Laxity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microfocused Ultrasound with Visualization (MFU-V)Device
Also called Ultherapy PRIME
Microfocused ultrasound with visualization (MFU-V) delivered using a standard single-depth treatment (1.5 mm transducer) to one randomized side of the face to improve facial skin laxity.
multi Microfocused Ultrasound with Visualization (MFU-V)Device
Also called Ultherapy PRIME
Microfocused ultrasound with visualization (MFU-V) delivered using a customized dual- or triple-depth treatment (1.5 mm, 3.0 mm, and when indicated 4.5 mm transducers) targeting the SMAS/fibromuscular layer on the contralateral randomized side of the face.
| Study group | Role | What they receive |
|---|---|---|
| Standard Single-Depth Ultherapy PRIME Treatment | Experimental | Participants receive microfocused ultrasound with visualization (Ultherapy PRIME) using a standard single-depth treatment (1.5 mm) on one randomized side of the face. Receives: Device: Microfocused Ultrasound with Visualization (MFU-V) |
| Customized Multi-Depth Ultherapy PRIME Treatment | Experimental | Participants receive customized microfocused ultrasound with visualization (Ultherapy PRIME) using dual- or triple-depth treatment (1.5 mm, 3.0 mm, and when indicated 4.5 mm) targeting the SMAS/fibromuscular layer on the contralateral randomized side of the face. Receives: Device: multi Microfocused Ultrasound with Visualization (MFU-V) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SMAS/Fibromuscular Layer Firmness
Difference between baseline and Day 180 in SMAS/fibromuscular layer stiffness measured using Shear-Wave Elastography.
Measured: Baseline and Day 180
Secondary outcomes (11)
Change From Baseline in Facial Soft-Tissue Displacement Measured by Vectra 3D Imaging
Facial tissue displacement, in millimeters (mm), measured by three-dimensional imaging with the Vectra 3D system (Canfield Scientific), compared between the single-depth (1.5 mm) side and the multi-depth side.
Time Frame : Baseline, Day 90, and Day 180
Measured: Baseline, Day 90, and Day 180
changes in dermal thickness
Histologic evaluation of treatment-induced change in dermal thickness. Unit of Measure: millimeters (mm)
Measured: Baseline and Day 180
Change in Skin elasticity measured by ElastiMeter
Instant skin elasticity (ISE), expressed in newtons per meter (N/m), measured by indentation with the ElastiMeter (Delfin Technologies) on each side of the face. Higher values indicate greater tissue resistance to indentation. Compared between the single-depth (1.5 mm) side and the multi-depth side.
Measured: Baseline, Day 90, and Day 180
Change in collagen type I regeneration
Histologic evaluation of collagen type I regeneration measured by immunohistochemistry, expressed as the percentage of collagen-I-positive area relative to total tissue area.
Unit of Measure: % positive area
Measured: Baseline and Day 180
Change in collagen type III regeneration
Histologic evaluation of collagen type III regeneration measured by immunohistochemistry, expressed as the percentage of collagen-III-positive area relative to total tissue area.
Unit of Measure: % positive area
Measured: Baseline and Day 180
Change in elastin regeneration
Histologic evaluation of elastin regeneration measured by elastin-specific staining/immunohistochemistry, expressed as the percentage of elastin-positive area relative to total tissue area.
Unit of Measure: % positive area
Measured: Baseline and Day 180
Change in proteoglycan content
Histologic evaluation of proteoglycan content measured by Alcian Blue/Safranin O staining or proteoglycan-specific immunohistochemistry, expressed as the percentage of stained area relative to total tissue area.
Unit of Measure: % positive area
Measured: Baseline and Day 180
Change in collagen fiber alignment
image-analysis-derived collagen fiber coherence/alignment, expressed as an orientation index ranging from 0 (random alignment) to 1 (perfect alignment).
Unit of Measure: orientation index (0-1), dimensionless
Measured: baseline and day 180
Change in elastin fiber alignment
Image-analysis-derived elastin fiber coherence/alignment, expressed as an orientation index ranging from 0 (random alignment) to 1 (perfect alignment).
Unit of Measure: orientation index (0-1), dimensionless
Measured: Baseline and day 180
Change in MMP-1 expression
Histologic evaluation of MMP-1 expression measured by immunohistochemistry, expressed as the percentage of MMP-1-positive cells relative to total cells.
Unit of Measure: % positive cells
Measured: Baseline and day 180
Change in MMP-3 expression
Histologic evaluation of MMP-3 expression measured by immunohistochemistry, expressed as the percentage of MMP-3-positive cells relative to total cells.
Unit of Measure: % positive cells
Measured: Baseline and Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start24 Jul 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Crossover
- Model description
- split-face
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ocean Clinic
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890987
- Sponsor's protocol ID
- VISION
- Status last verified
- Oct 2026
- First submitted
- 31 Jul 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Fatemi F, Najafian R, Sadri MA. New Ultherapy method: Utilizing novel surgical and anatomical concepts yields outstanding results. J Cosmet Dermatol. 2024 Sep;23(9):2882-2887. doi: 10.1111/jocd.16374. Epub 2024 May 21.
PubMed 38773827
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visualization-Guided SMAS Treatment to Optimize Nonsurgical Lifting (VISION): A Prospective, Single-Center, Randomized, Split-Face Phase IV Clinical Trial
- ClinicalTrials.gov ID
- NCT07890987
- Acronym / sponsor ID
- VISION
- Conditions
- Facial Skin Laxity
- Keywords
- Facial Skin Laxity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ocean ClinicResearch network
- Study start
- 24 Jul 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 23 Oct 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 VISION study is a prospective, randomized, single-center, split-face Phase IV clinical trial evaluating whether customized multi-depth microfocused ultrasound with visualization (Ultherapy PRIME) targeting the SMAS/fibromuscular layer provides superior tissue firmness and lifting compared with single-depth dermal treatment. Fifty adults with moderate-to-severe facial skin laxity will receive different treatments on each side of the face. The primary outcome is the change in SMAS/fibromuscular layer stiffness measured by shear-wave elastography at Day 180.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- split-face
| Arm | Type | Receives |
|---|---|---|
| Standard Single-Depth Ultherapy PRIME Treatment | Experimental | Device: Microfocused Ultrasound with Visualization (MFU-V)Participants receive microfocused ultrasound with visualization (Ultherapy PRIME) using a standard single-depth treatment (1.5 mm) on one randomized side of the face. |
| Customized Multi-Depth Ultherapy PRIME Treatment | Experimental | Device: multi Microfocused Ultrasound with Visualization (MFU-V)Participants receive customized microfocused ultrasound with visualization (Ultherapy PRIME) using dual- or triple-depth treatment (1.5 mm, 3.0 mm, and when indicated 4.5 mm) targeting the SMAS/fibromuscular layer on the contralateral randomized side of the face. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 35-80 years. SMAS/fibromuscular layer depth ≥3.0 mm. Able to provide informed consent. Willing to comply with study procedures. Likely to complete follow-up. Is willing to refrain from all non-study procedures in the face (e.g., dermal filler treatments, ablative or fractional laser, micro dermabrasion, micro needling, chemical peels, non-invasive skin tightening and/or surgical procedures, skin-irritating preparations, etc.) during participation in this investigation.
Key exclusion criteria (18 listed)
- • Current GLP-1 RA use.
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 |
|---|---|---|
| Microfocused Ultrasound with Visualization (MFU-V)Also: Ultherapy PRIMEMicrofocused ultrasound with visualization (MFU-V) delivered using a standard single-depth treatment (1.5 mm transducer) to one randomized side of the face to improve facial skin laxity. | Device | Standard Single-Depth Ultherapy PRIME Treatment |
| multi Microfocused Ultrasound with Visualization (MFU-V)Also: Ultherapy PRIMEMicrofocused ultrasound with visualization (MFU-V) delivered using a customized dual- or triple-depth treatment (1.5 mm, 3.0 mm, and when indicated 4.5 mm transducers) targeting the SMAS/fibromuscular layer on the contralateral randomized side of the face. | Device | Customized Multi-Depth Ultherapy PRIME Treatment |
Primary outcome
Change in SMAS/Fibromuscular Layer Firmness
Time frame: Baseline and Day 180
Difference between baseline and Day 180 in SMAS/fibromuscular layer stiffness measured using Shear-Wave Elastography.
11 secondary outcomes
Change From Baseline in Facial Soft-Tissue Displacement Measured by Vectra 3D Imaging
Time frame: Baseline, Day 90, and Day 180
changes in dermal thickness
Time frame: Baseline and Day 180
Change in Skin elasticity measured by ElastiMeter
Time frame: Baseline, Day 90, and Day 180
Change in collagen type I regeneration
Time frame: Baseline and Day 180
Change in collagen type III regeneration
Time frame: Baseline and Day 180
Change in elastin regeneration
Time frame: Baseline and Day 180
Change in proteoglycan content
Time frame: Baseline and Day 180
Change in collagen fiber alignment
Time frame: baseline and day 180
Change in elastin fiber alignment
Time frame: Baseline and day 180
Change in MMP-1 expression
Time frame: Baseline and day 180
Change in MMP-3 expression
Time frame: Baseline and Day 180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Background: PubMed 38773827Fatemi F, Najafian R, Sadri MA. New Ultherapy method: Utilizing novel surgical and anatomical concepts yields outstanding results. J Cosmet Dermatol. 2024 Sep;23(9):2882-2887. doi: 10.1111/jocd.16374. Epub 2024 May 21.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microfocused Ultrasound with Visualization (MFU-V) and multi Microfocused Ultrasound with Visualization (MFU-V) in people with Facial Skin Laxity, run by Ocean Clinic at 1 site in Spain.
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 1 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 23 Oct 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanessa Garcia (+34 951 775 518, admon@oceanclinic.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SMAS/Fibromuscular Layer Firmness (time frame: Baseline and Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07890987, which also lists 1 linked publication.
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 23 Oct 2026.