Clinical Trial

Effectiveness and Safety of the Ulthera® System for Skin Laxity in the Lower Face, Submentum and Neck

Recruiting
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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.
Protocol Amendment History 2 changes
critical Recruitment opened 2026-06-18
notable Trial sites expanded: 0 -> 7 locations 2026-06-18
Trial Details
NCT Number NCT07614997
Lead Sponsor Merz North America, Inc.
Collaborators: Ulthera, Inc
Conditions Cutis Laxa
Enrollment 218 participants
Start Date 2026-06-15
Primary Completion 2026-12 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-06-17