Evaluation of the Ulthera™ System for Obtaining Lift and Tightening of the Cheek Tissue
Status
Conditions
Treatments
Details and patient eligibility
About
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
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
103 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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