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

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ClinicalTrials.gov Identifier: NCT04795622
Recruitment Status : Active, not recruiting
First Posted : March 12, 2021
Last Update Posted : February 23, 2022
Sponsor:
Collaborator:
Ulthera, Inc
Information provided by (Responsible Party):
Merz North America, Inc.

Study Description
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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 of treatment with the Ulthera DeepSEE System for the improvement of skin laxity of the lower face and submental area.

Condition or disease Intervention/treatment Phase
Improvement in Skin Laxity of the Lower Face and Submentum Device: Ultherapy treatment Device: Untreated-control / delayed-treatment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Effectiveness and Safety of the Ulthera® DeepSEE® System for Treating Skin Laxity in the Lower Face and Submentum
Actual Study Start Date : March 16, 2021
Actual Primary Completion Date : January 18, 2022
Estimated Study Completion Date : March 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Ulthera System Device: Ultherapy treatment
Focused ultrasound energy delivered below the surface of the skin
Delayed-treatment Ulthera System Device: Untreated-control / delayed-treatment
Untreated-control, followed by Ultherapy treatment (focused ultrasound energy delivered below the surface of the skin)


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects with improvement in lower face and submental skin laxity at Day 90 comparing Day 90 photographs with baseline photographs [ Time Frame: From baseline to day 90 ]

Secondary Outcome Measures :
  1. Displacement of skin (mm) in the submentum at Day 90 compared to baseline [ Time Frame: From baseline to day 90 ]
  2. Proportion of subjects with any improvement on the Investigator Global Aesthetic Improvement Scale (iGAIS) at Day 90 compared to baseline photographs [ Time Frame: From baseline to day 90 ]
  3. Proportion of subjects with any improvement on the Subject Global Aesthetic Improvement Scale (sGAIS) at Day 90 compared to baseline photographs [ Time Frame: From baseline to day 90 ]
  4. Change from baseline in FACE-Q™ Satisfaction with Lower Face and Jawline score (Rasch-transformed) at Day 90 [ Time Frame: From baseline to day 90 ]

Eligibility Criteria
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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- 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 Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04795622


Locations
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China
Peking University First Hospital, Merz Investigational Site #0860003
Beijing, China, 100034
Air Force General Hospital, Merz Investigational Site #0860002
Beijing, China, 100142
Beijing Hospital, Plastic Surgery, Merz Investigational Site #0860029
Beijing, China, 100730
Shanghai 9th Hospital, Plastic Surgery, Merz Investigational Site #0860015
Shanghai, China, 200011
Huashan Hospital Shanghai, Merz Investigational Site #0860004
Shanghai, China, 200040
Sponsors and Collaborators
Merz North America, Inc.
Ulthera, Inc
Investigators
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Study Director: Merz Medical Expert Merz North America, Inc.
More Information
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Responsible Party: Merz North America, Inc.
ClinicalTrials.gov Identifier: NCT04795622    
Other Study ID Numbers: M960101056
First Posted: March 12, 2021    Key Record Dates
Last Update Posted: February 23, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases