Feasibility Study: Evaluation of the Ulthera® System for Treatment of Abdominal Tissue

Ulthera

Status

Completed

Conditions

Skin Crepiness

Skin Laxity

Treatments

Device: Ulthera System Treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT01708499

ULT-128

Details and patient eligibility

About

Enrolled subjects will receive one UltherapyTM treatment on the abdomen. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Full description

This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System for improving laxity/crepiness and texture of abdominal tissue. Changes from baseline in the laxity, crepiness and texture of abdominal skin will be assessed at each study follow-up visit. Global Aesthetic Improvement Scale scores, assessments of dermal thickness, and patient satisfaction questionnaires will also be obtained.

Enrollment

24 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 abdomen
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 in the abdomen.
Excessive skin laxity on the abdomen.
Significant scarring in areas to be treated.
Open wounds or lesions in the area to be treated.
Inability to understand the protocol or to give informed consent.
BMI equal to and greater than 30.