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Effectiveness and Safety of the Ulthera® System for Skin Laxity in the Lower Face, Submentum and Neck
Sponsor: Merz North America, Inc.
Summary
The purpose of this study is to demonstrate superiority of treatment with the Ulthera System compared to untreated control for the improvement of skin laxity of the lower face, submental area and neck and to demonstrate the safety of treatment with the Ulthera System for the improvement of skin laxity of the lower face, submental area and neck.
Official title: Evaluation of the Effectiveness and Safety of the Ulthera® System for Treating Skin Laxity in the Lower Face, Submentum and Neck
Key Details
Gender
All
Age Range
35 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
218
Start Date
2026-06-15
Completion Date
2027-03
Last Updated
2026-06-17
Healthy Volunteers
Yes
Conditions
Interventions
Ulthera System
Participants will receive treatment with the Ulthera system which consists of three primary components: the control unit, handpiece and interchangeable transducers.
Locations (7)
Merz Investigative Site
Beijing, Beijing Municipality, China
Merz Investigative Site
Beijing, Beijing Municipality, China
Merz Investigative Site
Guangzhou, Guangdong, China
Merz Investigative Site
Nanjing, Jiangsu, China
Merz Investigative Site
Xi'an, Shaanxi, China
Merz Investigative Site
Shanghai, Shanghai Municipality, China
Merz Investigative Site
Shanghai, Shanghai Municipality, China