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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: April 25, 2014
Last verified: April 2014
Results First Received: January 13, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Brachial Ptosis
Intervention: Device: Ulthera® System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment opened 6/29/2011 and the last subject was treated 11/28/2011. Subjects were recruited from the site's patient database.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ultherapy® Treatment Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms

Participant Flow:   Overall Study
    Ultherapy® Treatment  
STARTED     37  
COMPLETED     31  
NOT COMPLETED     6  
Lost to Follow-up                 2  
Withdrawal by Subject                 3  
Excluded from analysis as a BMI outlier                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Three subjects excluded due to subject withdrawal. One subject excluded from results analyses as an outlier, with a high Body Mass Index (BMI) and substantial weight gain during the study period.

Reporting Groups
  Description
Ultherapy® Treatment Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms

Baseline Measures
    Ultherapy® Treatment  
Number of Participants  
[units: participants]
  33  
Age  
[units: years]
Mean ( Full Range )
  40  
  ( 25 to 57 )  
Gender  
[units: participants]
 
Female     33  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     33  
Fitzpatrick Skin Type [1]
[units: Participants]
 
Type I     0  
Type II     0  
Type III     15  
Type IV     16  
Type V     2  
Type VI     0  
[1] Skin Type I = White;very fair,red or blonde hair blue eyes;freckles;Always burns, never tans Skin Type II = White, fair, red or blond hair; blue, hazel or green eyes;Usually burns, tans with difficulty Skin Type III = Cream white; fair with any eye or hair color (common); Sometimes mild burn, gradually tans Skin Type IV = Brown; typical Mediterranean Caucasian skin; Rarely burns, tans with ease Skin Type V = Dark Brown; mid-eastern skin types; Very rarely burns, tans easily Skin Type VI = Black; Never burns, tans very easily



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity   [ Time Frame: Baseline to 90 days post-treatment ]

2.  Secondary:   Quantitative Improvement in Skin Laxity   [ Time Frame: Baseline to 90 days post-treatment ]

3.  Secondary:   Change in Dermal Thickness   [ Time Frame: Baseline to 90 days post-treatment ]

4.  Secondary:   Change in Dermal Thickness   [ Time Frame: Baseline to180 days post-treatment ]

5.  Secondary:   Overall Aesthetic Improvement   [ Time Frame: Baseline to 60 days post-treatment ]

6.  Secondary:   Overall Aesthetic Improvement   [ Time Frame: Baseline to 90 days post-treatment ]

7.  Secondary:   Overall Aesthetic Improvement   [ Time Frame: Baseline to180 days post-treatment ]

8.  Secondary:   Patient Satisfaction   [ Time Frame: Baseline to 90 days post-treatment ]

9.  Secondary:   Patient Satisfaction   [ Time Frame: Baseline to 180 days post-treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
- Poor subject selection (high BMI with large volume arms enrolled rather than subjects with laxity and wrinkled skin)


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lisa Misell, Ph.D
Organization: Ulthera, Inc.
phone: 480-619-4069
e-mail: medaffairs@ulthera.com


No publications provided


Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01713933     History of Changes
Other Study ID Numbers: ULT-114
Study First Received: October 15, 2012
Results First Received: January 13, 2014
Last Updated: April 25, 2014
Health Authority: United States: Institutional Review Board