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

Feasibility Study: Evaluation of the Ulthera® System for Efficacious and Safe Treatment of Laxity/Crepiness and Texture of Abdominal Tissue

NCT01708499•Ulthera, Inc

View on ClinicalTrials.gov

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.

Eligibility

Age

25 - 60 years

Sex

ALL

Healthy Volunteers

Yes

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

Key Dates

Start Date

March 1, 2012

Primary Completion Date

January 1, 2013

Completion Date

April 1, 2013

Last Updated

November 24, 2017

Enrollment

ACTUAL participants

Conditions

Skin LaxitySkin Crepiness

Interventions

Ulthera System Treatment

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 24, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

An Evaluation of the Erchonia Laser As a Non-Invasive Treatment to Improve the Appearance of Skin Laxity

Prospective Clinical Investigation to Evaluate the Safety and Effectiveness of Juläine™ in Improving Gluteal Skin Laxity in Adults.

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