Feasibility Study: Lifting and Tightening of the Elbows

Ulthera

Status

Completed

Conditions

Skin Laxity

Treatments

Device: Ulthera System Treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT01708382

ULT-108

Details and patient eligibility

About

Up to 20 subjects will be treated. Treated subjects will receive one Ulthera® treatment on the elbows. 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 to improve skin laxity above the elbows. Masked assessment of pre- and post-treatment photos will be performed. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will also be obtained.

Enrollment

21 patients

Sex

All

Ages

21 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female, age 21 to 65 years.
Subject in good health.
Mild to moderate skin laxity on the elbows.
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.
Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control

Exclusion criteria

Presence of an active systemic or local skin disease that may affect wound healing.
Excessive subcutaneous fat around the elbows.
Excessive skin laxity around the elbows.
Significant scarring in areas to be treated.
Significant open wounds or lesions in the area to be treated