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

NCT07890987 | Recruiting DMC FDA Device

• 1 other identifier: VISION
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Facial Skin Laxity

Keywords

Facial Skin Laxity

Outcome Measures

Primary Outcomes (1)

• Change in SMAS/Fibromuscular Layer Firmness

  Difference between baseline and Day 180 in SMAS/fibromuscular layer stiffness measured using Shear-Wave Elastography.

  Baseline and Day 180

Secondary Outcomes (11)

• Change From Baseline in Facial Soft-Tissue Displacement Measured by Vectra 3D Imaging

  Baseline, Day 90, and Day 180

• changes in dermal thickness

  Baseline and Day 180

• Change in Skin elasticity measured by ElastiMeter

  Baseline, Day 90, and Day 180

• Change in collagen type I regeneration

  Baseline and Day 180

• Change in collagen type III regeneration

  Baseline and Day 180

Study Arms (2)

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.

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.

Device: multi Microfocused Ultrasound with Visualization (MFU-V)

Interventions

Microfocused Ultrasound with Visualization (MFU-V) DEVICE

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.

Also known as: Ultherapy PRIME

Standard Single-Depth Ultherapy PRIME Treatment

multi Microfocused Ultrasound with Visualization (MFU-V) DEVICE

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.

Also known as: Ultherapy PRIME

Customized Multi-Depth Ultherapy PRIME Treatment

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Ocean Clinic: lead

Study Sites (1)

Ocean Clinic

Marbella, Malaga, 29601, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 38773827 BACKGROUND

Central Study Contacts

Vanessa Garcia

CONTACT

+34 951 775 518; admon@oceanclinic.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: split-face

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: October 23, 2026
• Study Start: July 24, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-10

Locations

ES (1)