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Evaluation of Safety and Efficacy of Deoxycholic Acid Injection (ATX-101) in the Reduction of Submental Fat

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01305577
First received: February 10, 2011
Last updated: June 17, 2015
Last verified: June 2015
Results First Received: May 28, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Moderate or Severe Submental Fullness
Interventions: Drug: Deoxycholic acid injection
Drug: Placebo

  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
This study was conducted in 28 study centers in the European Union.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of a 12-week treatment period and a 12-week safety follow-up period.

Reporting Groups
  Description
Deoxycholic Acid Injection 1 mg/cm² Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
Deoxycholic Acid Injection 2 mg/cm² Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
Placebo Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Participant Flow:   Overall Study
    Deoxycholic Acid Injection 1 mg/cm²   Deoxycholic Acid Injection 2 mg/cm²   Placebo
STARTED   120   121   122 
Received Treatment   119   121   122 
COMPLETED   107   110   112 
NOT COMPLETED   13   11   10 
Adverse Event                2                2                1 
Withdrawal by Subject                7                5                6 
Lost to Follow-up                4                3                2 
Protocol Deviation                0                1                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.
Intent-to-treat population

Reporting Groups
  Description
Deoxycholic Acid Injection 1 mg/cm² Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
Deoxycholic Acid Injection 2 mg/cm² Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
Placebo Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
Total Total of all reporting groups

Baseline Measures
   Deoxycholic Acid Injection 1 mg/cm²   Deoxycholic Acid Injection 2 mg/cm²   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 120   121   122   363 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.8  (10.94)   46.7  (9.78)   46.6  (10.17)   46.4  (10.28) 
Age, Customized 
[Units: Participants]
       
18 - 50 years   77   79   72   228 
51 - 65 years   43   42   50   135 
Gender 
[Units: Participants]
       
Female   95   95   87   277 
Male   25   26   35   86 
Race/Ethnicity, Customized 
[Units: Participants]
       
Asian   0   0   1   1 
Black or African American   2   2   0   4 
Hispanic or Latino   5   2   3   10 
Native Hawaiian or Other Pacific Islander   1   0   0   1 
White   111   116   117   344 
Other   1   1   1   3 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 73.83  (11.518)   73.53  (12.413)   73.50  (12.126)   73.62  (11.994) 
Body Mass Index (BMI) 
[Units: Kg/m²]
Mean (Standard Deviation)
 25.94  (2.724)   25.66  (3.063)   25.54  (2.758)   25.71  (2.850) 
Fitzpatrick Skin Type [1] 
[Units: Participants]
       
I-III   108   109   99   316 
IV-VI   12   12   23   47 
[1]

Fitzpatrick Skin Type is a numerical classification schema for human skin color and typical response to ultraviolet (UV) light:

  • Type I: Pale white skin, blue/hazel eyes, blond/red hair; Always burns, does not tan.
  • Type II: Fair skin, blue eyes; Burns easily, tans poorly.
  • Type III: Darker white skin; Tans after initial burn.
  • Type IV: Light brown skin; Burns minimally, tans easily.
  • Type V: Brown skin; Rarely burns, tans darkly easily.
  • Type VI: Dark brown or black skin; Never burns, always tans darkly.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response   [ Time Frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) ]

2.  Primary:   Percentage of Participants With a Subject Self Rating Scale (SSRS) Response   [ Time Frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) ]

3.  Secondary:   Percentage of Participants With a CR-SMFRS 2-grade Response   [ Time Frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) ]

4.  Secondary:   Change From Baseline in CR-SMFRS Scores   [ Time Frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) ]

5.  Secondary:   Change From Baseline in SSRS Scores   [ Time Frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) ]

6.  Secondary:   Change From Baseline in Submental Fat Thickness   [ Time Frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) ]

7.  Secondary:   Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS)   [ Time Frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) ]

8.  Secondary:   Change From Baseline in Self-rating of Attractiveness   [ Time Frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) ]

9.  Secondary:   Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)   [ Time Frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) ]
Results not yet reported.   Anticipated Reporting Date:   01/2016   Safety Issue:   No

10.  Secondary:   Change From Baseline in Derriford Appearance Scale 24 (DAS24)   [ Time Frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) ]
Results not yet reported.   Anticipated Reporting Date:   01/2016   Safety Issue:   No

11.  Secondary:   Change From Baseline in Body Image Quality of Life Inventory (BIQLI)   [ Time Frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) ]
Results not yet reported.   Anticipated Reporting Date:   01/2016   Safety Issue:   No


  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
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  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Clinical Trial Disclosure
Organization: Kythera
e-mail: clinical_trials@kythera.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01305577     History of Changes
Other Study ID Numbers: ATX-101-10-16
2010-020690-17 ( EudraCT Number )
Study First Received: February 10, 2011
Results First Received: May 28, 2015
Last Updated: June 17, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency