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Reducing Wrinkles Around the Eyes Using the Ulthera® System

NCT ID: NCT01368900

Last Updated: 2017-12-13

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

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-01-31

Brief Summary

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The purpose of this prospective, multi-center, single treatment study is to evaluate the clinical outcomes associated with the non-invasive treatment to reduce wrinkles around the eyes utilizing the Ulthera® System to deliver focused ultrasound energy below the surface of the skin.

Detailed Description

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The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System for non-invasive treatment to reduce wrinkles around the eyes.

Conditions

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Periorbital Wrinkles

Keywords

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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

SINGLE

Outcome Assessors

Study Groups

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Ulthera System Treatment

Ulthera treatment to the upper face.

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

Eligibility Criteria

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Inclusion Criteria

* Male or female, aged 30 to 65 years.
* Subject in good health.
* Mild to moderate rhytids in the periorbital region.
* Willingness and ability to comply with protocol requirements and return for follow-up visits.
* Not pregnant.
* Provide written informed consent and HIPAA authorization.

Exclusion Criteria

* Presence of an active systemic or local skin disease that may affect wound healing.
* Severe solar elastosis.
* Excessive subcutaneous fat in the face.
* Deep wrinkles, numerous lines, with or without redundant skin in the area to be treated.
* Excessive hooding, with or without redundant skin, in the areas to be treated.
* 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.
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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Robert Weiss, M.D.

Role: PRINCIPAL_INVESTIGATOR

MD Laser Skin & Vein Institute

Brian Biesman, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Nashville Centre for Laser and Facial Surgery

Locations

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MD Laser Skin & Vein Institute

Hunt Valley, Maryland, United States

Site Status

The Nashville Centre for Laser and Facial Surgery

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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ULT-111

Identifier Type: -

Identifier Source: org_study_id