Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study
NCT ID: NCT01032889
Last Updated: 2015-06-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
129 participants
INTERVENTIONAL
2009-12-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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 6 treatments.
Placebo
Phosphate buffered saline placebo for injection
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 6 treatments.
Deoxycholic acid injection
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 6 treatments.
Deoxycholic acid injection
Interventions
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Deoxycholic acid injection
Placebo
Phosphate buffered saline placebo for injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Dissatisfaction with submental area
* History of stable body weight
* Signed informed consent
Exclusion Criteria
* Previous intervention in the submental area
18 Years
65 Years
ALL
Yes
Sponsors
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Kythera Biopharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Frederick Beddingfield, MD, PhD
Role: STUDY_DIRECTOR
Kythera Biopharmaceuticals, Inc.
Locations
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Investigational Site
Birmingham, Alabama, United States
Investigational Site
Beverly Hills, California, United States
Investigational Site
Beverly Hills, California, United States
Investigational Site
San Francisco, California, United States
Investigational Site
Naperville, Illinois, United States
Investigational Site
Chestnut Hill, Massachusetts, United States
Investigational Site
Fridley, Minnesota, United States
Investigational Site
St Louis, Missouri, United States
Investigational Site
Omaha, Nebraska, United States
Investigational Site
Plano, Texas, United States
Countries
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Other Identifiers
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ATX-101-09-15
Identifier Type: -
Identifier Source: org_study_id
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