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VISION Study: Visualization-Guided SMAS Treatment to Optimize Nonsurgical Lifting
Sponsor: Ocean Clinic
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 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.
Official title: Visualization-Guided SMAS Treatment to Optimize Nonsurgical Lifting (VISION): A Prospective, Single-Center, Randomized, Split-Face Phase IV Clinical Trial
Key Details
Gender
All
Age Range
35 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-07-24
Completion Date
2027-07-30
Last Updated
2026-10-23
Healthy Volunteers
Yes
Conditions
Interventions
Microfocused Ultrasound with Visualization (MFU-V)
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)
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.
Locations (1)
Ocean Clinic
Marbella, Malaga, Spain