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

Ulthera, Inc54 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Facial Skin Laxity

Interventions

Ulthera® System treatmentDEVICE

Ulthera® System treatment delivering focused ultrasound energy

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Harris Aesthetics, LLC

Chevy Chase, Maryland, United States

Dermatology, Cosmetic & Laser Surgery

Rockville, Maryland, United States

Outcomes

Primary Outcomes

Change in Overall Lifting and Tightening of Treated Tissue

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

Time frame: 90 days post treatment

Secondary Outcomes

Global Aesthetic Improvement at 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.

Time frame: 90 Days post-treatment

Global Aesthetic Improvement at 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.

Time frame: 180 days post-treatment

Patient Satisfaction Questionnaire

Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at three months (D90) post Ulthera treatment. Pre-treatment and Day 90 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.

Time frame: 90 Days post-treatment

Patient Satisfaction Questionnaire

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.

Data from ClinicalTrials.gov

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