Phase 3 Study of Deoxycholic Acid Injection (ATX-101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area (REFINE-1)
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ClinicalTrials.gov Identifier: NCT01542034 |
Recruitment Status :
Completed
First Posted : March 1, 2012
Results First Posted : June 15, 2015
Last Update Posted : June 15, 2015
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Sponsor:
Kythera Biopharmaceuticals
Information provided by (Responsible Party):
Kythera Biopharmaceuticals
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
Moderate or Severe Submental Fullness |
Interventions |
Drug: Deoxycholic acid injection Drug: Placebo |
Enrollment | 506 |
Participant Flow
Recruitment Details | The study was performed at 35 investigational centers in the United States (US) and Canada. |
Pre-assignment Details |
Arm/Group Title | Deoxycholic Acid Injection | Placebo |
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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 6 treatments. | 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 6 treatments. |
Period Title: Overall Study | ||
Started | 256 | 250 |
Received Treatment | 256 | 249 |
Completed | 226 [1] | 227 [1] |
Not Completed | 30 | 23 |
Reason Not Completed | ||
Consent Withdrawn (Subject Convenience) | 20 | 12 |
Administrative decision | 0 | 3 |
Subject Noncompliance | 1 | 0 |
Adverse Event | 2 | 2 |
Lost to Follow-up | 7 | 6 |
[1]
Participants who completed long-term follow-up 24 weeks after the last treatment
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Baseline Characteristics
Arm/Group Title | Deoxycholic Acid Injection | Placebo | Total | |
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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 6 treatments. | 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 6 treatments. | Total of all reporting groups | |
Overall Number of Baseline Participants | 256 | 250 | 506 | |
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Intention-to-treat population
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 256 participants | 250 participants | 506 participants | |
49.5 (9.30) | 49.4 (9.33) | 49.5 (9.30) | ||
Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 256 participants | 250 participants | 506 participants |
18 - 50 years | 122 | 121 | 243 | |
51 - 65 years | 134 | 129 | 263 | |
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 256 participants | 250 participants | 506 participants | |
Female |
213 83.2%
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208 83.2%
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421 83.2%
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Male |
43 16.8%
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42 16.8%
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85 16.8%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 256 participants | 250 participants | 506 participants |
White | 218 | 227 | 445 | |
Black or African American | 24 | 13 | 37 | |
Asian | 7 | 5 | 12 | |
American Indian or Alaskan Native | 0 | 2 | 2 | |
Native Hawaiian or Pacific Islander | 0 | 1 | 1 | |
Multiple | 2 | 0 | 2 | |
Other | 5 | 2 | 7 | |
Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 256 participants | 250 participants | 506 participants |
Hispanic or Latino | 28 | 17 | 45 | |
Non-Hispanic or Latino | 228 | 233 | 461 | |
Weight
[1] Mean (Standard Deviation) Unit of measure: Kg |
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Number Analyzed | 256 participants | 250 participants | 506 participants | |
81.15 (14.549) | 80.98 (14.296) | 81.07 (14.411) | ||
[1]
Measure Description: Data available for 256 and 249 participants in each treatment group respectively
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Body Mass Index (BMI)
[1] Mean (Standard Deviation) Unit of measure: Kg/m² |
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Number Analyzed | 256 participants | 250 participants | 506 participants | |
29.23 (4.406) | 29.26 (4.281) | 29.25 (4.340) | ||
[1]
Measure Description: Data available for 256 and 249 participants in each treatment group respectively
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Fitzpatrick Skin Type
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 256 participants | 250 participants | 506 participants |
I - III | 180 | 187 | 367 | |
IV - VI | 76 | 63 | 139 | |
[1]
Measure Description:
Fitzpatrick Skin Type is a numerical classification schema for human skin color and typical response to ultraviolet (UV) light:
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 Clinical Study Agreement requires that the investigator or institution obtain written consent from Kythera prior to presenting and/or publishing results of this study.
Results Point of Contact
Name/Title: | Clinical Trial Disclosure |
Organization: | Kythera |
EMail: | clinical_trials@kythera.com |
Responsible Party: | Kythera Biopharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01542034 |
Other Study ID Numbers: |
ATX-101-11-22 |
First Submitted: | February 24, 2012 |
First Posted: | March 1, 2012 |
Results First Submitted: | May 28, 2015 |
Results First Posted: | June 15, 2015 |
Last Update Posted: | June 15, 2015 |