Reducing Wrinkles Around the Eyes Using the Ulthera® System

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ulthera, Inc

ClinicalTrials.gov Identifier:

NCT01368900

First received: June 6, 2011

Last updated: October 15, 2012

Last verified: October 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Periorbital Wrinkles	Device: Ulthera® System treatment	Phase 4

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Evaluation of the Ulthera® System for Obtaining a Reduction of Wrinkles Around the Eyes

Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:

Overall improvement in periorbital wrinkles [ Time Frame: 90 days post-treatment compared to baseline ] [ Designated as safety issue: No ]
Improvement in periorbital skin laxity and rhytids as determined by masked assessor review of photographs at 90days post-treatment compared to baseline.

Enrollment:	70
Study Start Date:	March 2011
Study Completion Date:	January 2012
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ulthera System Treatment Ulthera treatment to the upper face.	Device: Ulthera® System treatment Focused ultrasound energy delivered below the surface of the skin. Other Name: Ultherapy

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	30 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368900

Locations

United States, Maryland
MD Laser Skin & Vein Institute
Hunt Valley, Maryland, United States, 21030
United States, Tennessee
The Nashville Centre for Laser and Facial Surgery
Nashville, Tennessee, United States, 37203

Sponsors and Collaborators

Ulthera, Inc

Investigators

Principal Investigator:	Robert Weiss, M.D.	MD Laser Skin & Vein Institute
Principal Investigator:	Brian Biesman, M.D.	The Nashville Centre for Laser and Facial Surgery

More Information

No publications provided

Responsible Party:	Ulthera, Inc
ClinicalTrials.gov Identifier:	NCT01368900 History of Changes
Other Study ID Numbers:	ULT-111
Study First Received:	June 6, 2011
Last Updated:	October 15, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Ulthera, Inc:

Ultherapy™ Treatment
Ulthera, Inc.
Ultrasound treatment for skin tightening

ClinicalTrials.gov processed this record on May 23, 2013

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