Clinical trial NCT04795622: Evaluation of the Effectiveness and Safety of the Ulthera® DeepSEE® System for Treating Skin Laxity in the Lower Face and Submentum
Official title: Evaluation of the Effectiveness and Safety of the Ulthera® DeepSEE® System for Treating Skin Laxity in the Lower Face and Submentum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Improvement in Skin Laxity of the Lower Face and Submentum
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Ulthera, Inc
First posted: 2021-03-12
Enrollment: 201
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Subjects in the study received a single treatment with Ulthera DeepSEE system on the midface, lower face, submental (under the chin) and upper neck area using 3 DeepSEE (DS) transducers (DS 10-1.5, DS 7-3.0, DS 7-4.5) at either Day 1 or Day 90. Subjects treated at Day 1 were followed for 180 days after treatment and subjects treated at Day 90 were followed for 90 days after treatment.

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.

Primary outcomes:
measure: Percentage of Subjects With Improvement in Lower Face and Submental Skin Laxity at Day 90
timeFrame: Day 90
Secondary outcomes:
measure: Displacement of Skin in the Submentum at Day 90
timeFrame: Day 90
measure: 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
timeFrame: Day 90
measure: 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
timeFrame: Day 90
measure: 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
timeFrame: Baseline up to Day 90
measure: Number of Subjects With at Least One Treatment-related Treatment-emergent Adverse Events (TEAEs)
timeFrame: From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital, Merz Investigational Site #0860003
city: Beijing
country: China
facility: Air Force General Hospital, Merz Investigational Site #0860002
city: Beijing
country: China
facility: Beijing Hospital, Plastic Surgery, Merz Investigational Site #0860029
city: Shanghai
country: China
facility: Shanghai 9th Hospital, Plastic Surgery, Merz Investigational Site #0860015
city: Shanghai
country: China
facility: Huashan Hospital Shanghai, Merz Investigational Site #0860004
Study officials:
affiliation: Merz North America, Inc.
name: Merz Medical Expert
role: STUDY_DIRECTOR
References: