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

Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Cheek Tissue and Improvement in Jawline Definition and Submental Skin Laxity in Patients With Fitzpatrick Skin Phototypes 3 Through 6

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.

Study Overview

• Status: Completed
• Conditions: Facial Skin Laxity
• Intervention / Treatment: Device: Ulthera® System treatment

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Harris Aesthetics, LLC
    • Rockville, Maryland, United States, 20852
      • Dermatology, Cosmetic & Laser Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ulthera® System treatment	Device: Ulthera® System treatment; Ulthera® System treatment delivering focused ultrasound energy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	90 days post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	180 days post-treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Assessment of Pain	Subject assessment of pain using a validated Numeric Rating Scale (NRS), 0-10, where 0 = no pain and 10=worse pain possible. Subjects' sensory responses to the treatment exposures were recorded using the NRS for each anatomical region.	During Ulthera treatment

Collaborators and Investigators

• Sponsor: Ulthera, Inc
• Investigators: Principal Investigator: Hema Sundaram, M.D., Dermatology, Cosmetic & Laser Surgery; Principal Investigator: Monte O Harris, M.D., Harris Aesthetics, LLC

Publications and helpful links

General Publications

• Harris MO, Sundaram HA. Safety of Microfocused Ultrasound With Visualization in Patients With Fitzpatrick Skin Phototypes III to VI. JAMA Facial Plast Surg. 2015 Sep-Oct;17(5):355-7. doi: 10.1001/jamafacial.2015.0990.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: June 6, 2011
• First Submitted That Met QC Criteria: June 7, 2011
• First Posted (Estimate): June 8, 2011

Study Record Updates

• Last Update Posted (Actual): December 13, 2017
• Last Update Submitted That Met QC Criteria: November 16, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases, Genetic; Cutis Laxa
• Other Study ID Numbers: ULT-112