Status:
COMPLETED
Evaluation of the Effectiveness and Safety of the Ulthera® DeepSEE® System for Treating Skin Laxity in the Lower Face and Submentum
Lead Sponsor:
Merz North America, Inc.
Collaborating Sponsors:
Ulthera, Inc
Conditions:
Improvement in Skin Laxity of the Lower Face and Submentum
Eligibility:
All Genders
35-65 years
Phase:
NA
Brief 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...
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...
Eligibility Criteria
Inclusion
- \- Mild to moderate lower face and/or submental laxity that is amenable to improvement with non-invasive intervention and is not severe enough for surgical intervention;
Exclusion
- Scarring in area(s) to be treated;
- Any active implants (e.g., pacemakers or defibrillators) in the area(s) to be treated;
- Any metallic implants in area(s) to be treated;
- Any open wounds or lesions in the area(s) to be treated;
- Body mass index (BMI) less than 19 or greater than 30; or
- Gain or loss of ≥ 2 BMI units within the previous 90 days or has the intention to gain or lose ≥ 2 BMI units during the course of the trial.
Key Trial Info
Start Date :
March 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2022
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT04795622
Start Date
March 16 2021
End Date
May 17 2022
Last Update
March 23 2023
Active Locations (5)
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1
Peking University First Hospital, Merz Investigational Site #0860003
Beijing, China, 100034
2
Air Force General Hospital, Merz Investigational Site #0860002
Beijing, China, 100142
3
Beijing Hospital, Plastic Surgery, Merz Investigational Site #0860029
Beijing, China, 100730
4
Shanghai 9th Hospital, Plastic Surgery, Merz Investigational Site #0860015
Shanghai, China, 200011