N/A
N=103
Evaluation of the Ulthera™ System for Obtaining Lift and Tightening of the Cheek Tissue
Mild to Moderate Skin Laxity on Cheek · Mild to Moderate Skin Laxity on Upper Neck · Mild to Moderate Subcutaneous Fat on Cheek · Mild to Moderate Subcutaneous Fat on Upper Neck
Bottom Line
View on ClinicalTrials.gov: NCT01368835 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcome: Primary: Change in Overall Lifting and Tightening of Treated Tissue on the Lower Face and Submental Regions. — 68.60 percentage of participants improved
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ulthera treatment (Device)
- Age
- Adult · 35+ yrs
- Sex
- All
- Sponsor
- Ulthera, Inc
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Overall Lifting and Tightening of Treated Tissue on the Lower Face and Submental Regions. |
68.60 | — |
| SECONDARY Change in Submental and Neck Skin Laxity by Quantitative Analysis |
72.9 | — |
| SECONDARY Patient Satisfaction Questionnaire |
67 | — |
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01368835). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.