N/A Completed N=103 Single-blind Treatment

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

Source: ClinicalTrials.gov NCT01368835 ↗

Enrolled (actual)

103

Serious AEs

0.0%

Results posted

Aug 2013

Primary outcomePrimary: Change in Overall Lifting and Tightening of Treated Tissue on the Lower Face and Submental Regions. — 68.60 percentage of participants improved

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

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.