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

Ulthera

Status

Completed

Conditions

Skin Laxity of the décolleté

Treatments

Device: Ulthera® System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01485107

ULT-105

Details and patient eligibility

About

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.

Full description

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.

Enrollment

24 patients

Sex

Female

Ages

35 to 60 years old

Volunteers

Accepts Healthy Volunteers

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