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Lifting and Tightening of the Face and Neck Utilizing the Ulthera® System

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01368874
First Posted: June 8, 2011
Last Update Posted: May 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ulthera, Inc
Results First Submitted: June 3, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Facial and Neck Skin Laxity
Intervention: Device: Ulthera® System treatment

  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
The study was conducted at two private medical clinics. Seventy-one 71 subjects enrolled, of which 64 subjects received study treatment February and July of 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Seven enrolled subjects did not receive a complete study treatment. Six subjects were deemed screen failures, and one subject withdrew consent after receiving only a partial treatment. Sixty-four 64)subjects were assigned in a non-randomized fashion to each treatment group at the discretion of the PI.

Reporting Groups
  Description
Group A Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
Group B Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
Group C Dual depth treatment on the submental, submandibular and lower neck regions.

Participant Flow:   Overall Study
    Group A   Group B   Group C
STARTED   34   5   25 
COMPLETED   31   5   24 
NOT COMPLETED   3   0   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.
No text entered.

Reporting Groups
  Description
Group A Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
Group B Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
Group C Dual depth treatment on the submental, submandibular and lower neck regions.
Total Total of all reporting groups

Baseline Measures
   Group A   Group B   Group C   Total 
Overall Participants Analyzed 
[Units: Participants]
 34   5   25   64 
Age 
[Units: Years]
Mean (Full Range)
 55.06 
 (43 to 65) 
 57.4 
 (49 to 62) 
 55.2 
 (39 to 65) 
 55.3 
 (39 to 65) 
Gender 
[Units: Participants]
       
Female   32   5   24   61 
Male   2   0   1   3 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   2   0   5   7 
Not Hispanic or Latino   32   5   20   57 
Unknown or Not Reported   0   0   0   0 
Fitzpatrick Skin Type Score [1] 
[Units: Participants]
       
Type I   6   0   4   10 
Type II   18   5   8   31 
Type III   10   0   12   22 
Type IV   0   0   0   0 
Type V   0   0   1   1 
[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

BMI 
[Units: Kg/m^2]
Mean (Full Range)
 25.53 
 (19.04 to 32.76) 
 22.49 
 (19.58 to 27.1) 
 26.32 
 (18.47 to 36.44) 
 25.60 
 (18.47 to 36.44) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity   [ Time Frame: 90 Days post-treatment ]

2.  Primary:   Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity - RE-ANALYZED GROUP   [ Time Frame: 90 Days post-treatment ]

3.  Secondary:   Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.   [ Time Frame: 60 days post-treatment ]

4.  Secondary:   Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.   [ Time Frame: 90 days post-treatment ]

5.  Secondary:   Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity , as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.   [ Time Frame: 180 days post-treatment ]

6.  Secondary:   Patient Satisfaction 90 Days Post-treatment   [ Time Frame: 90 Days post-treatment ]

7.  Secondary:   Patient Satisfaction Questionnaire 180 Days Post-treatment   [ Time Frame: 180 days post-treatment ]

8.  Secondary:   L'Oreal Photographic Scale Baseline   [ Time Frame: Baseline ]

9.  Secondary:   L'Oreal Photographic Scale 90 Days Post-treatment   [ Time Frame: 90 Days post-treatment ]

10.  Secondary:   L'Oreal Photographic Scale 180 Days Post-treatment   [ Time Frame: 180 Days post-treatment ]

11.  Other Pre-specified:   Subjects' Assessment of Pain   [ Time Frame: During Ulthera 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
No text entered.


  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., VP, Clinical and Medical Affairs
Organization: Ulthera, Inc.
phone: 480-619-4069



Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01368874     History of Changes
Other Study ID Numbers: ULT-110
First Submitted: June 6, 2011
First Posted: June 8, 2011
Results First Submitted: June 3, 2013
Results First Posted: November 20, 2013
Last Update Posted: May 5, 2014