Evaluation of the Effectiveness and Safety of the Ulthera™ System for the Treatment of Wrinkles Around the Eyes

NCT ID: NCT00747422

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-05-31

Brief Summary

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The purpose of this study is to look at how safe and effective the Ulthera ultrasound system is at reducing the appearance of wrinkles when used with subjects who have wrinkles around the eyes.

Detailed Description

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The purpose of this prospective, multi-center, single treatment, clinical trial is to evaluate the effectiveness and safety of the Ulthera™ System for the non-invasive treatment of periorbital wrinkles and rhytids.

Conditions

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Periorbital Wrinkles

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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I

Group Type EXPERIMENTAL

Ulthera™ System

Intervention Type DEVICE

ultrasound treatment

Interventions

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Ulthera™ System

ultrasound treatment

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or female, aged 40 to 70 years
* Subject in good health
* Desire improvement in periorbital wrinkles
* Subject provides informed consent and agrees to attend follow-up visits
* Subject signs a HIPPA authorization

Exclusion Criteria

* Pregnant or lactating
* Has an active systemic or local skin disease that may alter wound healing
* Has significant scarring in test areas
* Has significant open facial wounds or lesions
* Has severe or cystic acne on the face
* Has a metal stent or implant in the face area
* Is a current smoker or has a history of smoking in last 10 years
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 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

Locations

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Scripps Clinic Carmel Valley, Division of Laser and Cosmetic Dermatology

San Diego, California, United States

Site Status

Northwestern University Department of Dermatology

Chicago, Illinois, United States

Site Status

SkinCare Physicians

Chestnut Hill, Massachusetts, United States

Site Status

Zel Skin and Laser Specialists

Edina, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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ULT-102

Identifier Type: -

Identifier Source: org_study_id