Evaluation of the Ulthera® System for Treatment of the Brachia

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ulthera, Inc

ClinicalTrials.gov Identifier:

NCT01713933

First received: October 15, 2012

Last updated: February 27, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 15, 2012

Last Updated Date

February 27, 2013

Start Date ^ICMJE

June 2011

Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Improvement in obtaining lift and tightening of brachial skin laxity [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]

Assess improvement based on a masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01713933 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Quantitative improvement in skin laxity [ Time Frame: Participants will be followed up to 180 days post-treatment ] [ Designated as safety issue: No ]
Assess change in brachial volume based on brachial tissue measurements.
Improvement in dermal thickness [ Time Frame: Participants will be followed for up to 180 days following treatment #2. ] [ Designated as safety issue: No ]
Based on ultrasonic skin analysis
Overall aesthetic improvement [ Time Frame: 90 and 180 days post-treatment ] [ Designated as safety issue: No ]
Based on GAIS scores
Patient satisfaction [ Time Frame: 90 and 180 days post-treatment ] [ Designated as safety issue: No ]
Based on Patient Satisfaction questionnaires

Original Secondary Outcome Measures ^ICMJE

Same as current

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 Treatment of the Brachia

Official Title ^ICMJE

Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Brachia

Brief Summary

This study is an evaluation of the Ulthera® System used to treat the upper arms for improvement of brachial ptosis. All enrolled subjects will receive one bilateral upper arm treatment. Follow-up visits will occur at 60, 90 and 180 days post-treatment.

Detailed Description

This is a prospective, non-randomized, clinical trial treating up to 35 subjects. Study photographs of the upper arms will be taken prior to treatment, immediately post-treatment, and at each follow-up visit. Brachial volume and dermal thickness measurements will be obtained.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Brachial Ptosis

Intervention ^ICMJE

Device: Ulthera® System

Focused ultrasound energy delivered below the surface of the skin.

Other Names:

Ulthera® System
Ultherapy™ treatment
Ulthera, Inc.
Ultrasound treatment for skin tightening

Study Arm (s)

Experimental: Ultherapy™ treatment

Each enrolled subject will receive a bilateral Ultherapy™ treatment of the upper arms

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

Completion Date

May 2012

Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or female, aged 19 - 55 years.
Subject in good health.
Subjects who desire lift and tightening of the brachia and improvement in skin laxity.
Mild to moderate laxity of the upper arm.
Mild to moderate subcutaneous fat of the upper arm.
Mild crepiness of the skin of the upper arm.
Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.

Exclusion Criteria:

Presence of an active systemic or local skin disease that may affect wound healing.
Severe solar elastosis.
Excessive subcutaneous fat in the upper arm.
Excessive skin laxity in the upper arm.
Significant scarring in areas to be treated.
Significant open wounds or lesions in the treatment areas. 7. Severe or cystic acne in the treatment areas.

Gender

Both

Ages

19 Years to 55 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

NCT01713933

Other Study ID Numbers ^ICMJE

ULT-114

Has Data Monitoring Committee

Responsible Party

Ulthera, Inc

Study Sponsor ^ICMJE

Ulthera, Inc

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Gordon Sasaki, MD FACS

Sasaki Advanced Aesthetic Medical Center

Information Provided By

Ulthera, Inc

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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