NCT04795622

Brief Summary

  1. 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. 2.Demonstrate the safety of treatment with the Ulthera DeepSEE System for the improvement of skin laxity of the lower face and submental area.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

March 16, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2022

Completed
9 months until next milestone

Results Posted

Study results publicly available

February 15, 2023

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

March 9, 2021

Results QC Date

January 18, 2023

Last Update Submit

March 21, 2023

Conditions

Improvement in Skin Laxity of the Lower Face and Submentum

Outcome Measures

Primary Outcomes (1)

  • Percentage of Subjects With Improvement in Lower Face and Submental Skin Laxity at Day 90

    Lower face and submental skin laxity were determined by three blinded evaluators after comparing Day 90 photographs with baseline photographs. Improvement was concluded if at least two evaluators assessed the Day 90 photographs as "improved" compared to baseline.

    Day 90

Secondary Outcomes (5)

  • Displacement of Skin in the Submentum at Day 90

    Day 90

  • 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

    Day 90

  • 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

    Day 90

  • 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

    Baseline up to Day 90

  • Number of Subjects With at Least One Treatment-related Treatment-emergent Adverse Events (TEAEs)

    From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180)

Study Arms (2)

Treatment Ulthera System

EXPERIMENTAL
Device: Ultherapy treatment

Delayed-treatment Ulthera System

OTHER
Device: Untreated-control / delayed-treatment

Interventions

Ultherapy treatmentDEVICE

Focused ultrasound energy delivered below the surface of the skin

Treatment Ulthera System
Untreated-control / delayed-treatmentDEVICE

Untreated-control, followed by Ultherapy treatment (focused ultrasound energy delivered below the surface of the skin)

Delayed-treatment Ulthera System

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Peking University First Hospital, Merz Investigational Site #0860003

Beijing, 100034, China

Location

Air Force General Hospital, Merz Investigational Site #0860002

Beijing, 100142, China

Location

Beijing Hospital, Plastic Surgery, Merz Investigational Site #0860029

Beijing, 100730, China

Location

Shanghai 9th Hospital, Plastic Surgery, Merz Investigational Site #0860015

Shanghai, 200011, China

Location

Huashan Hospital Shanghai, Merz Investigational Site #0860004

Shanghai, 200040, China

Location

MeSH Terms

Interventions

Treatment Delay

Intervention Hierarchy (Ancestors)

Time-to-TreatmentPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Public Disclosure Manager
Organization
Merz Aesthetics
Aesthetic.Trials@merz.com
+49 69 1503

Study Officials

  • Merz Medical Expert

    Merz North America, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2021

First Posted

March 12, 2021

Study Start

March 16, 2021

Primary Completion

January 18, 2022

Study Completion

May 17, 2022

Last Updated

March 23, 2023

Results First Posted

February 15, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(5)