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Evaluation of the Effectiveness and Safety of the Ulthera® DeepSEE® System for Treating Skin Laxity in the Lower Face and Submentum

NCT04795622 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2023-03-23

Study results available
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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.

Conditions

  • Improvement in Skin Laxity of the Lower Face and Submentum

Interventions

DEVICE

Ultherapy treatment

Focused ultrasound energy delivered below the surface of the skin

DEVICE

Untreated-control / delayed-treatment

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

Sponsors & Collaborators

  • Ulthera, Inc

    collaborator INDUSTRY

  • Merz North America, Inc.

    lead INDUSTRY

Principal Investigators

  • Merz Medical Expert · Merz North America, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-16
Primary Completion
2022-01-18
Completion
2022-05-17
FDA Device
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04795622 on ClinicalTrials.gov