Visualization-guided SMAS lifting with ultrasound for facial laxity
Official title: Visualization-Guided SMAS Treatment to Optimize Nonsurgical Lifting (VISION): A Prospective, Single-Center, Randomized, Split-Face Phase IV Clinical Trial
Run by Ocean Clinic · NCT07890987 · Data updated 2026-11-12
This study tests whether a visualization-guided multi-depth ultrasound treatment on one side of the face provides firmer tissue and a stronger lift than a single-depth dermal treatment in adults with moderate-to-severe facial laxity.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 35 Years to 80 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Ocean Clinic Research network |
| Locations | 1 site (Marbella, Malaga) |
| Status | Recruiting |
| Started | July 24, 2026 |
| Main results expected | January 1, 2027 |
| Study ends | July 30, 2027 |
| Registry record updated | October 23, 2026 |
| Trial ID | NCT07890987 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 35-80 with SMAS/fibromuscular layer depth of at least 3.0 mm and moderate-to-severe facial laxity who consent to the study and comply with follow-up.
✕Probably not a fit
Individuals outside the depth criteria, unwilling to refrain from non-study facial procedures, or who do not complete follow-up may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this prospective, randomized, single-center study, adults with moderate-to-severe facial skin laxity will receive two different ultrasound treatments on opposite sides of the face. The multi-depth MFU-V treatment targets the SMAS/fibromuscular layer and is compared to a single-depth dermal approach. The primary outcome is the change in stiffness of the SMAS/fibromuscular layer measured by shear-wave elastography at 180 days. The trial is Phase IV and open-label, with each participant serving as their own control. Enrollment is limited to adults aged 35-80 who meet the depth and consent requirements and are willing to refrain from other facial procedures during participation.
Why it matters
Potential benefit: If successful, the approach could improve facial firmness and lifting with a personalized, depth-targeted ultrasound treatment.
How similar studies have gone: Previous work with ultrasound-guided facial lifting has shown tissue changes with MFU-V, but this specific multi-depth, visualization-guided, split-face design for flipping sides is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * • 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 * 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
Where it's running
-
Ocean Clinic
Marbella, Malaga, Spain Recruiting
Study contacts
- Study coordinator: Vanessa Garcia
- Email: admon@oceanclinic.net
- Phone: +34 951 775 518
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.