Status:
COMPLETED
Phase 1-2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat
Lead Sponsor:
Kythera Biopharmaceuticals
Conditions:
Moderate or Severe Submental Fullness
Eligibility:
All Genders
25-65 years
Phase:
PHASE1
PHASE2
Brief Summary
To evaluate the safety and potential efficacy of deoxycholic acid injection compared to placebo for the reduction of submental fat (fat below the chin).
Detailed Description
The trial included an initial cohort (3 participants in each arm) to evaluate safety followed by expansion to a second, larger cohort if adequate safety was determined in the initial cohort. Data from...
Eligibility Criteria
Inclusion
- Submental fat (SMF) that was considered undesirable by the subject and graded by the investigator as 2 or 3 using the SMF rating scale
- Good general health
- Signed informed consent
Exclusion
- History of any treatment in the neck or chin area
- Loose skin or prominent platysmal bands in the neck or chin area
- Recent treatment with anticoagulants
- Presence of clinically significant health problems
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00618722
Start Date
August 1 2007
End Date
October 1 2008
Last Update
July 14 2015
Active Locations (6)
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1
Investigational Site
Carina Heights, Australia
2
Investigational Site
Gold Coast, Australia
3
Investigational Site
Toorak, Australia
4
Investigational Site
Oakville, Ontario, Canada