NCT04795622

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Merz North America, Inc. · Industry
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Improvement in Skin Laxity of the Lower Face and Submentum

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2021-03-16
• Primary completion: 2022-01-18
• Completion: 2022-05-17
• First posted: 2021-03-12
• Last updated: 2023-03-23
• Results posted: 2023-02-15

Locations

5 sites across 1 country: China

Regulatory

• FDA-regulated device study