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

Not Applicable

Completed

• Conditions: Skin Laxity; Skin Crepiness
• Interventions: Device: Ulthera System Treatment

• Registration Number: NCT01708499
• Lead Sponsor: Ulthera, Inc

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-10-15
• Study First Submitted QC: 2012-10-16
• Study First Posted: 2012-10-17
• Primary Completion: 2013-01
• Study Completion: 2013-04
• Status Verified: 2013-06
• Last Update Submitted: 2017-11-21
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study treatment	Ulthera System Treatment	All enrolled subjects will receive one Ulthera System Treatment.

Primary Outcome Measures

Name	Time	Method
Improvement laxity/crepiness and texture of abdominal tissue	90 days post-treatment	Determined by a masked, qualitative assessment of photographs at 90 days post treatment compared to baseline

Secondary Outcome Measures

Name	Time	Method
Overall aesthetic improvement	180 days post-treatment	The Global Aesthetic Improvement Scale scores will be obtained from the investigator and subject, comparing post-treatment photos to pre-treatment photos.

Trial Locations

Locations (1)

Sasaki Advanced Aesthetic Medical Center; 🇺🇸 Pasadena, California, United States