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

Not Applicable

Completed

• Conditions: Skin Laxity of the décolleté
• Interventions: Device: Ulthera® System

• Registration Number: NCT01485107
• Lead Sponsor: Ulthera, Inc

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-12-01
• Study First Submitted QC: 2011-12-02
• Study First Posted: 2011-12-05
• Primary Completion: 2012-01
• Study Completion: 2012-05
• Status Verified: 2013-06
• Last Update Submitted: 2017-11-22
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultherapy™ treatment on the décolleté	Ulthera® System	All enrolled subjects will receive the study treatment.

Primary Outcome Measures

Name	Time	Method
Improvement in overall lifting and tightening of skin	90 days post-treatment	Lifting and tightening of décolleté skin as determined by a masked, qualitative assessment of photographs at 90 days posttreatment compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	90 and 180 days post-treatment	Subject-completed questionnaire.
Overall aesthetic improvement	90 and 180 days post-treatment	Based on Global Aesthetic Improvement Scale (GAIS) scores.
Skin Laxity of the Décolleté	90 and 180 days post-treatment	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.
Bilateral chest measurements	90 and 180 days post-treatment	Measurements from mid-clavicle to nipple obtained at each follow-up visit compared to baseline to assess for lifting and tightening of skin.

Trial Locations

Locations (1)

Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser; 🇺🇸 San Diego, California, United States