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RECRUITING
NCT07890987
NA

VISION Study: Visualization-Guided SMAS Treatment to Optimize Nonsurgical Lifting

Sponsor: Ocean Clinic

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

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