N/A
Completed N=32
Lifting and Tightening of the Face and Neck Following an Increased Density Treatment
Skin Laxity
Source: ClinicalTrials.gov NCT01519206 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Improvement in Overall Lifting and Tightening of Skin — 48 percentage of participants improved
Summary
The purpose of this study is to evaluate the Ulthera® System for obtaining lift and tightening of the cheek tissue, reduction of jowling, and improving jawline definition and/or submental skin laxity when increased density treatment is applied.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Improvement in Overall Lifting and Tightening of Skin |
48 | — |
| SECONDARY Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment. |
7; 14; 7; 7; 28; 24 | — |
| SECONDARY Subjects' Assessment of Pain |
4.6; 3.6 | — |
| SECONDARY Subject Satisfaction at 90 Days, 180 Days and 1 Year Post-treatment |
21; 10; 7; 48; 59; 41 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female, aged 30 to 65 years
- Subject in good health
- Desires lift and tightening of cheek tissue, reduction of jowling, improvement of jawline definition and/or submental skin laxity
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period
- Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study
Exclusion Criteria
- Presence of an active systemic or local skin disease that may affect wound healing
- Severe solar elastosis
- Excessive subcutaneous fat on the cheeks
- Excessive skin laxity on the lower face and neck
- Significant scarring in areas to be treated
- Significant open facial wounds or lesions
- Severe or cystic acne on the face
- Presence of a metal stent or implant in the facial area to be treated, a pacemaker, or cochlear implants
Data sourced from ClinicalTrials.gov (NCT01519206). 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. Informational only — not medical advice.