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Lifting and Tightening of the Face and Neck Following an Increased Density Treatment

NCT ID: NCT01519206

Last Updated: 2017-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-03-31

Brief Summary

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The purpose of this study is to evaluate the Ulthera® System for obtaining lift and tightening of the cheek tissue, reduction of jowling, and improving jawline definition and/or submental skin laxity when increased density treatment is applied.

Detailed Description

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All enrolled study subjects will receive one full face and neck Ultherapy™ treatment. Pre- and post-treatment photos will be taken. Subjects will be required to return for follow-up visits at 60 days, 90 days, 180 days and 1 year following treatment.

Conditions

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Skin Laxity

Keywords

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Ulthera® System Ultherapy™ Treatment Ulthera, Inc.

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

Ulthera System Treatment

Group Type EXPERIMENTAL

Ulthera System Treatment

Intervention Type DEVICE

Focused ultrasound energy delivered below the surface of the skin.

Interventions

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Ulthera System Treatment

Focused ultrasound energy delivered below the surface of the skin.

Intervention Type DEVICE

Other Intervention Names

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Ultherapy™ Ulthera, Inc. Ultrasound treatment for skin tightening

Eligibility Criteria

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Inclusion Criteria

* Male or female, aged 30 to 65 years
* Subject in good health
* Desires lift and tightening of cheek tissue, reduction of jowling, improvement of jawline definition and/or submental skin laxity
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup 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
* Severe solar elastosis
* Excessive subcutaneous fat on the cheeks
* Excessive skin laxity on the lower face and neck
* Significant scarring in areas to be treated
* Significant open facial wounds or lesions
* Severe or cystic acne on the face
* Presence of a metal stent or implant in the facial area to be treated, a pacemaker, or cochlear implants
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

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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Roy Geronemus, M.D.

Role: PRINCIPAL_INVESTIGATOR

Laser & Skin Surgery Center of NY

Locations

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Laser & Skin Surgery Center of NY

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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ULT-124

Identifier Type: -

Identifier Source: org_study_id