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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened
    • Trial sites expanded: 0 → 7 locations
    • Start date changed from estimate of Jun 2026 to Jun 15, 2026
    v3
  2. Re-verified, no change to tracked fieldsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07614997
Lead Sponsor Merz North America, Inc.
Collaborators: Ulthera, Inc
Conditions
(from sponsor)		 Cutis Laxa
Related terms Cutis Laxa
Enrollment 218 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov