๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Adults aged 35-80 years. SMAS/fibromuscular layer depth โฅ3.0 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:
* โข 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