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



Status:Completed
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:35 - 60
Updated:11/25/2017
Start Date:June 2011
End Date:May 2012

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Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Décolleté

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.

This is a prospective, single-center study. Baseline Fabi/Bolton 5-Point Chest Wrinkle scale
scores and chest measurements will be assessed prior to study treatment. Study images will be
obtained pre-treatment, immediate post-treatment, and at each follow-up visit.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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
We found this trial at
1
site
9339 Genesee Avenue
San Diego, California 92121
?
mi
from
San Diego, CA
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