Evaluation of the Ulthera® System for Treatment of the Brachia

Completed · Not applicable

Conditions studied: Brachial Ptosis

In brief

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.

Key facts

Study ID

NCT01713933

Run by

Ulthera, Inc

People needed

37

Starts

2011-06-01

Expected to finish

2012-05-01

Last updated by the study team

2017-12-11

Who can join

Age: 19 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sasaki Advanced Aesthetic Medical Center — Pasadena, California, United States

Full record on ClinicalTrials.gov

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