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

NCT ID: NCT01485107

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-05-31

Brief Summary

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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

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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.

Conditions

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Skin Laxity of the décolleté

Keywords

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Ulthera® System Ultherapy™ treatment Ulthera, Inc. Ultrasound treatment for skin tightening

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ultherapy™ treatment on the décolleté

All enrolled subjects will receive the study treatment.

Group Type EXPERIMENTAL

Ulthera® System

Intervention Type DEVICE

Focused ultrasound energy delivered below the surface of the skin.

Interventions

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Ulthera® System

Focused ultrasound energy delivered below the surface of the skin.

Intervention Type DEVICE

Other Intervention Names

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Ultherapy™ treatment

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ulthera, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Goldman, MD

Role: PRINCIPAL_INVESTIGATOR

Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser

Locations

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Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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ULT-105

Identifier Type: -

Identifier Source: org_study_id