Evaluation of the Ulthera™ System For Obtaining Lift and Tightening of the Cheek Tissue and Improvement in Jawline Definition and Submental Skin Laxity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ulthera, Inc
- Enrollment
- 103
- Primary Endpoint
- Change in Overall Lifting and Tightening of Treated Tissue on the Lower Face and Submental Regions.
Study Overview
Brief Summary
The clinical trial evaluates the clinical outcomes associated with the non-invasive treatment to obtain lift and tightening of the cheek tissue and improve jawline definition and submental skin laxity utilizing the Ulthera™ System which delivers ultrasound energy in a focused manner below the surface of the skin
Detailed Description
The primary objective of this study is to demonstrate the effectiveness of the Ulthera™ System for the non-invasive dermatological treatment to obtain lift and tighten the cheek tissue.
The secondary objective of this study is to demonstrate the effectiveness of the Ulthera™ System for the non-invasive dermatological treatment for improvement in jawline definition and submental skin laxity at 3 and 6 months compared to baseline based on the consensus of the three masked reviewers.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 35 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male or female, aged 35 to 60 years
- •Subject in good health
- •Desire lift and tightening of cheek tissue, improvement of jawline definition or submental skin laxity
Exclusion Criteria
- •Pregnant or lactating
- •Has an active systemic or local skin disease that may alter wound healing
- •Severe solar elastosis
- •Excessive subcutaneous fat on the cheeks
- •Excessive skin laxity on the lower face and neck
- •Has significant scarring in areas to be treated
- •Has significant open facial wounds or lesions
- •Has severe or cystic acne on the face
Arms & Interventions
Ulthera treatment
Intervention: Ulthera treatment (Device)
Outcomes
Primary Outcomes
Change in Overall Lifting and Tightening of Treated Tissue on the Lower Face and Submental Regions.
Time Frame: 90D
The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos from 70 subjects who returned for their 90-day follow-up visit.
Secondary Outcomes
- Change in Submental and Neck Skin Laxity by Quantitative Analysis(90D)
- Patient Satisfaction Questionnaire(90D)