N/A
N=201
Evaluation of the Effectiveness and Safety of the Ulthera® DeepSEE® System for Treating Skin Laxity in the Lower Face and Submentum
Improvement in Skin Laxity of the Lower Face and Submentum
Bottom Line
View on ClinicalTrials.gov: NCT04795622 ↗Enrolled (actual)
201
Serious AEs
1.6%
Results posted
Feb 2023
Primary outcome: Primary: Percentage of Subjects With Improvement in Lower Face and Submental Skin Laxity at Day 90 — 54.2; 47.0 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ultherapy treatment (Device); Untreated-control / delayed-treatment (Device)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Merz North America, Inc.
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Improvement in Lower Face and Submental Skin Laxity at Day 90 |
54.2; 47.0 | — |
| SECONDARY Displacement of Skin in the Submentum at Day 90 |
-0.0229; 0.0571; -0.1693; -0.1352; -0.2279; -0.4086 | — |
| SECONDARY Percentage of Subjects With Any Improvement on the Investigator Global Aesthetic Improvement Scale (iGAIS) at Day 90 as Assessed by the Treating Investigator in the Treatment Group |
96.8 | — |
| SECONDARY Percentage of Subjects With Any Improvement on the Subject Global Aesthetic Improvement Scale (sGAIS) at Day 90 as Assessed by the Subjects in the Treatment Group |
94.7 | — |
| SECONDARY Change From Baseline in FACE-Q Satisfaction With Lower Face and Jawline Score (Rasch-transformed) at Day 90, as Assessed by Subjects in Treatment Group |
30.3 | — |
| SECONDARY Number of Subjects With at Least One Treatment-related Treatment-emergent Adverse Events (TEAEs) |
36; 34 | — |
Summary
1. Demonstrate superiority of treatment with the Ulthera DeepSEE System compared to untreated control for the improvement of skin laxity of the lower face and submental area.
2. Demonstrate the safety of treatment with the Ulthera DeepSEE System for the improvement of skin laxity of the lower face and submental area.
Eligibility Criteria
Inclusion Criteria
- Mild to moderate lower face and/or submental laxity that is amenable to improvement with non-invasive intervention and is not severe enough for surgical intervention;
Exclusion Criteria
- Scarring in area(s) to be treated;
- Any active implants (e.g., pacemakers or defibrillators) in the area(s) to be treated;
- Any metallic implants in area(s) to be treated;
- Any open wounds or lesions in the area(s) to be treated;
- Body mass index (BMI) less than 19 or greater than 30; or
- Gain or loss of ≥ 2 BMI units within the previous 90 days or has the intention to gain or lose ≥ 2 BMI units during the course of the trial.
Data sourced from ClinicalTrials.gov (NCT04795622). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.