Evaluation of the Ulthera® System for Treatment of the Face and Neck

Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Facial Tissue and Improvement in Jawline Definition and Submental Skin Laxity

Up to 15 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 45, 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Study Overview

• Status: Terminated
• Conditions: Wrinkles; Skin Laxity; Rhytids
• Intervention / Treatment: Device: Ulthera® Treatment

Detailed Description

This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve jawline definition and submental skin laxity. Changes from baseline in the Fitzpatrick Facial Wrinkle Scale and facial pigmentation will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores, patient satisfaction questionnaires, and quality of life questionnaires will be obtained.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • 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.
• Score of 1 to 6 on the Fitzpatrick's Classification of Wrinkling Scale.
• Mild to moderate rhytids in the periorbital or perioral region.
• Mild to moderate laxity in the areas to be treated, which includes length and depth of lines.
• Mild to moderate vertical perioral lines
• Mild to moderate marionette lines.
• Subjects who desire lift and tightening of periorbital, perioral, and cheek tissue, improvement in 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 follow-up 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 cheek.
• Excessive skin laxity on the lower face and neck.
• Deep wrinkles, numerous lines, with or without redundant skin in the areas to be treated.
• Excessive hooding with or without redundant skin in the areas to be treated.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ulthera® treatment; All enrolled subjects will receive one full face and neck Ulthera® treatment.	Device: Ulthera® Treatment; Focused ultrasound energy delivered below the surface of the skin.; Other Names: Ulthera, Inc.; Ultherapy™ System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in facial wrinkles and lifting and tightening of skin	Outcome measure determined based on a masked, qualitative assessment of standardized photographs at 90 days post-treatment compared to baseline	90 days post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall aesthetic improvement	Aesthetic improvement determined based on GAIS scores at follow-up, and the change in facial pigmentation and Fitzpatrick Facial Wrinkle Scale scores from baseline.	Participants will be followed up to 180 days post-treatment
Overall patient satisfaction	Determined based on Patient Satisfaction and Quality of Life questionnaire scores.	90 and 180 day post-treatment

Collaborators and Investigators

• Sponsor: Ulthera, Inc
• Investigators: Principal Investigator: Hema Sundaram, MD, Dermatology, Cosmetic & Laser Surgery

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): January 1, 2012

Study Registration Dates

• First Submitted: October 15, 2012
• First Submitted That Met QC Criteria: October 22, 2012
• First Posted (ESTIMATE): October 25, 2012

Study Record Updates

• Last Update Posted (ACTUAL): November 24, 2017
• Last Update Submitted That Met QC Criteria: November 22, 2017
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Ulthera® System; Ulthera, Inc.; Ultrasound treatment for skin tightening; Ultherapy™ treatment
• Additional Relevant MeSH Terms: Skin Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases, Genetic; Cutis Laxa
• Other Study ID Numbers: ULT-109