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

• ClinicalTrials.gov Identifier: NCT01713907
• Recruitment Status: Terminated
• First Posted: October 25, 2012
• Last Update Posted: November 24, 2017
• Sponsor: Ulthera, Inc
• Information provided by (Responsible Party): Merz North America, Inc. ( Ulthera, Inc )

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Wrinkles; Rhytids; Skin Laxity	Device: Ulthera® Treatment	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Facial Tissue and Improvement in Jawline Definition and Submental Skin Laxity
• Study Start Date: June 2011
• Actual Primary Completion Date: October 2011
• Actual Study Completion Date: January 2012

Arms and Interventions

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: Ultherapy™ System; Ulthera, Inc.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Maryland

Dermatology, Cosmetic & Laser Surgery

Rockville, Maryland, United States, 20852

Sponsors and Collaborators

Ulthera, Inc

Investigators

• Principal Investigator: Hema Sundaram, MD; Dermatology, Cosmetic & Laser Surgery

More Information

• Responsible Party: Ulthera, Inc
• ClinicalTrials.gov Identifier: NCT01713907
• Other Study ID Numbers: ULT-109
• First Posted: October 25, 2012
• Last Update Posted: November 24, 2017
• Last Verified: February 2013

Keywords provided by Merz North America, Inc. ( Ulthera, Inc ):

Ultherapy™ treatment; Ulthera® System; Ulthera, Inc.; Ultrasound treatment for skin tightening

Additional relevant MeSH terms:

Cutis Laxa; Skin Diseases, Genetic; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases