Feasibility Study: Lifting and Tightening of the Elbows

Not Applicable

Completed

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

• Registration Number: NCT01708382
• Lead Sponsor: Ulthera, Inc

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2012-09
• Study First Submitted: 2012-10-15
• Study First Submitted QC: 2012-10-16
• Study First Posted: 2012-10-17
• Study Completion: 2013-02
• Status Verified: 2013-06
• Last Update Submitted: 2017-11-21
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultherapy treatment on the elbows	Ulthera System Treatment	All enrolled subjects will receive one Ultherapy treatment to the elbows.

Primary Outcome Measures

Name	Time	Method
Overall improvement of skin laxity in the areas treated	90 days post-treatment	Determined by masked assessment analysis of photographs at 90 days post treatment compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Aesthetic improvement	90 and 180 days post-treatment	GAIS scores will be obtained by the Investigator and subjects at all visits excluding baseline. Additionally, subject satisfaction questionnaires will also be obtained.

Trial Locations

Locations (1)

New York Cosmetic, Skin and Laser Surgery Center; 🇺🇸 New York, New York, United States