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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ulthera, Inc

ClinicalTrials.gov Identifier:

NCT00747422

First received: September 3, 2008

Last updated: October 15, 2012

Last verified: October 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	September 3, 2008
Last Updated Date	October 15, 2012
Start Date ^ICMJE	July 2008
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 15, 2012)	reduction of periorbital wrinkles [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00747422 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluation of the Effectiveness and Safety of the Ulthera™ System for the Treatment of Wrinkles Around the Eyes
Official Title ^ICMJE	Evaluation of the Effectiveness and Safety of the Ulthera™ System for the Treatment of Periorbital Wrinkles
Brief Summary	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	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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label
Condition ^ICMJE	Periorbital Wrinkles
Intervention ^ICMJE	Device: Ulthera™ System ultrasound treatment
Study Arm (s)	Experimental: I Intervention: Device: Ulthera™ System
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	100
Completion Date	May 2009
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	40 Years to 70 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00747422
Other Study ID Numbers ^ICMJE	ULT-102
Has Data Monitoring Committee	No
Responsible Party	Ulthera, Inc
Study Sponsor ^ICMJE	Ulthera, Inc
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Ulthera, Inc
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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