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

Ulthera, Inc24 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Skin Laxity Skin Crepiness

Interventions

Ulthera System TreatmentDEVICE

Focused ultrasound energy delivered below the surface of the skin

Eligibility

Sex: ALLMin age: 25 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Sasaki Advanced Aesthetic Medical Center

Pasadena, California, United States

Outcomes

Primary Outcomes

Improvement laxity/crepiness and texture of abdominal tissue

Determined by a masked, qualitative assessment of photographs at 90 days post treatment compared to baseline

Time frame: 90 days post-treatment

Secondary Outcomes

Overall aesthetic improvement

The Global Aesthetic Improvement Scale scores will be obtained from the investigator and subject, comparing post-treatment photos to pre-treatment photos.

Time frame: 180 days post-treatment

Data from ClinicalTrials.gov

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