Lifting and Tightening of the Face in Subjects With Skin of Darker Color

Not Applicable

Completed

• Conditions: Facial Skin Laxity
• Interventions: Device: Ulthera® System treatment

• Registration Number: NCT01368965
• Lead Sponsor: Ulthera, Inc

Brief Summary

This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with non-invasive treatment to obtain lift and tightening of facial tissue and improve jawline definition in subjects with darker skin color utilizing the Ulthera® System to deliver focused ultrasound energy below the skin surface.

Detailed Description

The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System for the non-invasive treatment to obtain overall lift and tightening of facial tissue and jawline definition improvement.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-06-06
• Study First Submitted QC: 2011-06-07
• Study First Posted: 2011-06-08
• Primary Completion: 2011-10
• Study Completion: 2012-08
• Results First Submitted: 2014-02-10
• Results First Submitted QC: 2014-02-10
• Results First Posted: 2014-03-26
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-16
• Last Update Posted: 2017-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Male or female, aged 30 to 65 years.
• Subject in good health.
• Subjects who desire lift and tightening of cheek tissue, improvement in jawline definition and/or submental skin laxity.
• Fitzpatrick skin phototypes of 3 through 6.
• Provide written informed consent and HIPAA authorization

Exclusion Criteria

• Pregnant or lactating.
• Presence of an active systemic or local skin disease that may affect wound healing.
• Severe solar elastosis.
• Excessive subcutaneous fat on the cheek.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ulthera® System treatment	Ulthera® System treatment	-

Primary Outcome Measures

Name	Time	Method
Change in Overall Lifting and Tightening of Treated Tissue	90 days post treatment	The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction Questionnaire	180 days post-treatment	Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at six months (D180) post Ulthera treatment. Pre-treatment and Day 180 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.
Global Aesthetic Improvement at 90 Days Post-treatment	90 Days post-treatment	At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale.
Global Aesthetic Improvement at 180 Days Post-treatment	180 days post-treatment	At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale.

Trial Locations

Locations (2)

Dermatology, Cosmetic & Laser Surgery; 🇺🇸 Rockville, Maryland, United States

Harris Aesthetics, LLC; 🇺🇸 Chevy Chase, Maryland, United States