Lifting and Tightening of the Face and Neck Following an Increased Density Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01519206
First received: December 8, 2011
Last updated: May 22, 2014
Last verified: May 2014
Results First Received: March 20, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Skin Laxity
Intervention: Device: Ulthera System Treatment

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Thirty-five (35) subjects were enrolled, 3 were deemed screen failures. Thirty-two (32) received study treatment. The first subject was treated on August 3, 2011 and the last subject was treated on 11/28/2011. The last patient follow-up for the trial was 11/21/2012.

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 Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.

Participant Flow:   Overall Study
    Ultherapy Treatment  
STARTED     32  
COMPLETED     27  
NOT COMPLETED     5  
Lost to Follow-up                 3  
Missed Visit                 2  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Ultherapy Treatment Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.

Baseline Measures
    Ultherapy Treatment  
Number of Participants  
[units: participants]
  32  
Age  
[units: years]
Mean ( Full Range )
  55  
  ( 44 to 64 )  
Gender  
[units: participants]
 
Female     31  
Male     1  
Race/Ethnicity, Customized  
[units: participants]
 
Caucasian     30  
African American/Black     1  
Hispanic/Latino     1  
Region of Enrollment  
[units: participants]
 
United States     32  
Fitzpatrick Skin Type [1]
[units: participants]
 
I     1  
II     24  
III     6  
IV     0  
V     1  
VI     0  
Body Mass Index (BMI)  
[units: kg/m˄2]
Mean ( Full Range )
  23.3  
  ( 18.0 to 30.2 )  
[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 Overall Lifting and Tightening of Skin   [ Time Frame: Baseline to 90 days post treatment ]

2.  Secondary:   Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment.   [ Time Frame: Baseline to 60 days, 90 days, 180 days and 1 year post-treatment ]

3.  Secondary:   Subjects' Assessment of Pain   [ Time Frame: During Ulthera treatment ]

4.  Secondary:   Subject Satisfaction at 90 Days, 180 Days and 1 Year Post-treatment   [ Time Frame: Baseline to 90 days, 180 days and 1 year post-treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
3-D digital imaging was not completed, thus quantitative measure of submental skin lift was not obtained.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Lisa Misell, Ph.D., VP, Clinical and Medical Affairs
Organization: Ulthera, Inc.
phone: 480-619-4069


No publications provided


Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01519206     History of Changes
Other Study ID Numbers: ULT-124
Study First Received: December 8, 2011
Results First Received: March 20, 2014
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board