Evaluation of the Ulthera™ System for Obtaining Lift and Tightening of the Cheek Tissue

This study has been completed.

Sponsor:

Collaborator:

University of Texas Southwestern Medical Center

Information provided by (Responsible Party):

Ulthera, Inc

ClinicalTrials.gov Identifier:

NCT01368835

First received: June 6, 2011

Last updated: October 15, 2012

Last verified: October 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 6, 2011
Last Updated Date	October 15, 2012
Start Date ^ICMJE	July 2010
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 15, 2012)	Improvement in overall lifting and tightening of skin [ Time Frame: 3 month and 6 month compared to baseline ] [ Designated as safety issue: No ] Improvement in overall lifting and tightening of skin determined by qualitative assessment of photographs at 3 month and 6 month compared to baseline based on a masked reviewer assessment.
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01368835 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 15, 2012)	Evaluation of improvement in jawline definition and submental skin laxity [ Time Frame: 3 and 6 months post treatment ] [ Designated as safety issue: No ] Evaluation of improvement in jawline definition and submental skin laxity at 3 and 6 months compared to baseline based on the consensus of the three masked reviewers.
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 Ulthera™ System for Obtaining Lift and Tightening of the Cheek Tissue
Official Title ^ICMJE	Evaluation of the Ulthera™ System For Obtaining Lift and Tightening of the Cheek Tissue and Improvement in Jawline Definition and Submental Skin Laxity
Brief Summary	The clinical trial evaluates the clinical outcomes associated with the non-invasive treatment to obtain lift and tightening of the cheek tissue and improve jawline definition and submental skin laxity utilizing the Ulthera™ System which delivers ultrasound energy in a focused manner below the surface of the skin
Detailed Description	The primary objective of this study is to demonstrate the effectiveness of the Ulthera™ System for the non-invasive dermatological treatment to obtain lift and tighten the cheek tissue. The secondary objective of this study is to demonstrate the effectiveness of the Ulthera™ System for the non-invasive dermatological treatment for improvement in jawline definition and submental skin laxity at 3 and 6 months compared to baseline based on the consensus of the three masked reviewers.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Mild to Moderate Skin Laxity on Cheek Mild to Moderate Skin Laxity on Upper Neck Mild to Moderate Subcutaneous Fat on Cheek Mild to Moderate Subcutaneous Fat on Upper Neck
Intervention ^ICMJE	Device: Ulthera treatment treatment of cheeks and upper neck area of face
Study Arm (s)	Experimental: Ulthera treatment Intervention: Device: Ulthera treatment
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	103
Completion Date	April 2011
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Male or female, aged 35 to 60 years Subject in good health Desire lift and tightening of cheek tissue, improvement of jawline definition or submental skin laxity Exclusion Criteria: Pregnant or lactating Has an active systemic or local skin disease that may alter wound healing Severe solar elastosis Excessive subcutaneous fat on the cheeks Excessive skin laxity on the lower face and neck Has significant scarring in areas to be treated Has significant open facial wounds or lesions Has severe or cystic acne on the face
Gender	Both
Ages	35 Years to 60 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01368835
Other Study ID Numbers ^ICMJE	ULT-106
Has Data Monitoring Committee	Yes
Responsible Party	Ulthera, Inc
Study Sponsor ^ICMJE	Ulthera, Inc
Collaborators ^ICMJE	University of Texas Southwestern Medical Center
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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