Lifting and Tightening of the Face in Subjects With Skin of Darker Color

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01368965
First received: June 6, 2011
Last updated: February 10, 2014
Last verified: February 2014
Results First Received: February 10, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Facial 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
Subjects desiring lift/tightening of cheek tissue, or improved jawline definition and/or submental skin laxity, and were Fitzpatrick skin types 3-6 were recruited. Fifty-four subjects were enrolled at two facilities. Study recruitment initiated 2/16/11; follow-up concluded 1/18/12.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Fifty-four subjects who met study eligibility requirements were assigned a study subject ID. Two subjects withdrew from the study due prior to study treatment. Data from these subjects are not included in the demographic summaries or in the efficacy analyses. Fifty-two subjects received study treatment.

Reporting Groups
  Description
Treated Subjects All treated study subjects received a full face Ulthera® treatment.

Participant Flow:   Overall Study
    Treated Subjects  
STARTED     52 [1]
Subject Withdrawal Prior to Treatment     2  
COMPLETED     40  
NOT COMPLETED     12  
Lost to Follow-up                 12  
[1] Two subjects withdrew consent prior to study treatment. Data analyses are based on 52 subjects.



  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.
Fifty-four subjects were consented and enrolled. Two subjects withdrew consent prior to treatment. Data analyses are based on 52 treated subjects.

Reporting Groups
  Description
Treated Subjects Study subjects who received a full face Ulthera treatment. (n=52)

Baseline Measures
    Treated Subjects  
Number of Participants  
[units: participants]
  52  
Age  
[units: years]
Mean ( Full Range )
  53  
  ( 32 to 64 )  
Gender  
[units: participants]
 
Female     51  
Male     1  
Race/Ethnicity, Customized  
[units: participants]
 
African American/Black     35  
Hispanic/Latino     5  
Asian     10  
Other     2  
Region of Enrollment  
[units: participants]
 
United States     52  
Fitzpatrick Skin Type [1]
[units: participants]
 
Type III     9  
Type IV     25  
Type V     15  
Type VI     3  
[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
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1.  Primary:   Change in Overall Lifting and Tightening of Treated Tissue   [ Time Frame: 90 days post treatment ]

2.  Secondary:   Global Aesthetic Improvement at 90 Days Post-treatment   [ Time Frame: 90 Days post-treatment ]

3.  Secondary:   Global Aesthetic Improvement at 180 Days Post-treatment   [ Time Frame: 180 days post-treatment ]

4.  Secondary:   Patient Satisfaction Questionnaire   [ Time Frame: 90 Days post-treatment ]

5.  Secondary:   Patient Satisfaction Questionnaire   [ Time Frame: 180 days post-treatment ]

6.  Other Pre-specified:   Subject 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

Study Limitations:

  • Masked assessment was not completed as photos were not usable, i.e., poor image quality, positioning and timing.
  • Site staffing changes.
  • Overburdened site staff.
  • Poor photography quality
  • Subject selection


  More Information
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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: NCT01368965     History of Changes
Other Study ID Numbers: ULT-112
Study First Received: June 6, 2011
Results First Received: February 10, 2014
Last Updated: February 10, 2014
Health Authority: United States: Institutional Review Board