N/A N=32 Treatment

Lifting and Tightening of the Face and Neck Following an Increased Density Treatment

Skin Laxity

Bottom Line

View on ClinicalTrials.gov: NCT01519206 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2014

Primary outcome: Primary: Improvement in Overall Lifting and Tightening of Skin — 48 percentage of participants improved

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Ulthera System Treatment (Device)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: Ulthera, Inc
Primary completion: Feb 2012

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	—

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.

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

View full record on ClinicalTrials.gov →

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.