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

Ulthera, Inc24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Skin Laxity of the décolleté

Interventions

Ulthera® SystemDEVICE

Focused ultrasound energy delivered below the surface of the skin.

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser

San Diego, California, United States

Outcomes

Primary Outcomes

Improvement in overall lifting and tightening of skin

Lifting and tightening of décolleté skin as determined by a masked, qualitative assessment of photographs at 90 days posttreatment compared to baseline.

Time frame: 90 days post-treatment

Secondary Outcomes

Skin Laxity of the Décolleté

The amount of skin laxity will be assessed using the Fabi/Bolton 5-Point Chest Wrinkle Scale. Skin laxity will be assessed at each follow-up visit compared to baseline.

Time frame: 90 and 180 days post-treatment

Bilateral chest measurements

Measurements from mid-clavicle to nipple obtained at each follow-up visit compared to baseline to assess for lifting and tightening of skin.

Time frame: 90 and 180 days post-treatment

Overall aesthetic improvement

Based on Global Aesthetic Improvement Scale (GAIS) scores.

Time frame: 90 and 180 days post-treatment

Patient satisfaction

Subject-completed questionnaire.

Time frame: 90 and 180 days post-treatment

Data from ClinicalTrials.gov

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