Lifting and Tightening of the Face and Neck Following an Increased Density Treatment

NCT ID: NCT01519206

Last Updated: 2017-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-03-31

Brief Summary

The purpose of this study is to evaluate the Ulthera® System for obtaining lift and tightening of the cheek tissue, reduction of jowling, and improving jawline definition and/or submental skin laxity when increased density treatment is applied.

Detailed Description

All enrolled study subjects will receive one full face and neck Ultherapy™ treatment. Pre- and post-treatment photos will be taken. Subjects will be required to return for follow-up visits at 60 days, 90 days, 180 days and 1 year following treatment.

Conditions

Skin Laxity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ultherapy treatment

Ulthera System Treatment

Group Type: EXPERIMENTAL

Ulthera System Treatment

Intervention Type: DEVICE

Focused ultrasound energy delivered below the surface of the skin.

Interventions

Ulthera System Treatment

Focused ultrasound energy delivered below the surface of the skin.

Intervention Type: DEVICE

Other Intervention Names

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

Eligibility Criteria

Inclusion Criteria

• Male or female, aged 30 to 65 years
• Subject in good health
• Desires lift and tightening of cheek tissue, reduction of jowling, improvement of 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 followup 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 cheeks
• 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, a pacemaker, or cochlear implants

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ulthera, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roy Geronemus, M.D.

Role: PRINCIPAL_INVESTIGATOR

Laser & Skin Surgery Center of NY

Locations

Laser & Skin Surgery Center of NY

New York, New York, United States

Countries

United States

Other Identifiers

ULT-124

Identifier Type: -

Identifier Source: org_study_id