Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Décolleté

Completed · Not applicable

Conditions studied: Skin Laxity of the décolleté

In brief

Up to 20 subjects will be enrolled. Subjects will receive treatment of the décolleté using the Ulthera® System. Subjects will be return for follow-up visits at 90 and 180 days post-treatment. The study will evaluate the effectiveness of the Ulthera® System to lift and tighten the skin of the décolleté region.

Key facts

Study ID: NCT01485107
Run by: Ulthera, Inc
People needed: 24
Starts: 2011-06-01
Expected to finish: 2012-05-01
Last updated by the study team: 2017-11-24

Who can join

Age: 35 and older, up to 60. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Female, aged 35 to 60 years.
Subject in good health.
Moderate to severe (grade of ≥3 on Fabi/Bolton scale) skin laxity on the décolleté.
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.
Scarring in areas to be treated.
Tattoos in the areas to be treated.
Patients with ports or defibrillators.
Breast size >400cc each as measured by water displacement method.
History of breast reduction surgery.
Any open wounds or lesions in the area.
Active and severe inflammatory acne in the region to be treated.
Patients who have a history with keloid formation or hypertropic scarring

Where it is running

Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser — San Diego, California, United States

Full record on ClinicalTrials.gov

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