Feasibility Study: Higher Density Ulthera® System Treatment With Vectoring for Treatment of the Face and Neck

Ulthera

Status

Completed

Conditions

Skin Laxity

Treatments

Device: Ulthera System Treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT01708512

ULT-130

Details and patient eligibility

About

All enrolled subject will receive one Ultherapy™ treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each study follow-up visit. Enrolled subjects will return for follow-up visits at 90 days, 180 days and 365 days post-treatment.

Full description

This is a prospective, single-center clinical trial to evaluate the efficacy of the Ulthera® System to provide a customized, high-density, vectored Ultherapy™ treatment to lift and tighten the skin of the face and neck. Skin laxity changes from baseline will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will also be obtained.

Enrollment

21 patients

Sex

All

Ages

25 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female, aged 25 to 60 years.
Subject in good health.
Skin laxity in the area(s) to be treated.
Understands and accepts the obligation not to undergo any other procedures in the area(s) 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 in the area(s) to be treated.
Excessive skin laxity on the area(s) to be treated.
Significant scarring in area(s) to be treated.
Open wounds or lesions in the area(s) to be treated.
Severe or cystic acne on the area(s) to be treated.
Presence of a metal stent or implant in the area(s) to be treated.
Inability to understand the protocol or to give informed consent.
BMI equal to and greater than 30.