Evaluation of the Ulthera® System for Treatment of the Brachia

Ulthera

Status

Completed

Conditions

Brachial Ptosis

Treatments

Device: Ulthera® System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01713933

ULT-114

Details and patient eligibility

About

This study is an evaluation of the Ulthera® System used to treat the upper arms for improvement of brachial ptosis. All enrolled subjects will receive one bilateral upper arm treatment. Follow-up visits will occur at 60, 90 and 180 days post-treatment.

Full description

This is a prospective, non-randomized, clinical trial treating up to 35 subjects. Study photographs of the upper arms will be taken prior to treatment, immediately post-treatment, and at each follow-up visit. Brachial volume and dermal thickness measurements will be obtained.

Enrollment

37 patients

Sex

All

Ages

19 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female, aged 19 - 55 years.
Subject in good health.
Subjects who desire lift and tightening of the brachia and improvement in skin laxity.
Mild to moderate laxity of the upper arm.
Mild to moderate subcutaneous fat of the upper arm.
Mild crepiness of the skin of the upper arm.
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 upper arm.
Excessive skin laxity in the upper arm.
Significant scarring in areas to be treated.
Significant open wounds or lesions in the treatment areas. 7. Severe or cystic acne in the treatment areas.