Status:
COMPLETED
Phase 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:
PHASE2
Brief Summary
Phase 2 trial to evaluate the safety and potential efficacy of one concentration of deoxycholic acid injection, given in three dosing paradigms, compared to placebo for the reduction of submental fat ...
Eligibility Criteria
Inclusion
- Submental fat that was considered undesirable by the subject and graded by the investigator as 2 or 3 using the submental fat (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 :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00618618
Start Date
April 1 2008
End Date
December 1 2008
Last Update
July 14 2015
Active Locations (7)
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1
Investigational Site
Toorak, Victoria, Australia, 3142
2
Investigational Site
Sydney, Australia, 2000
3
Investigational Site
Niagara Falls, Ontario, Canada, L2E 7H1
4
Investigational Site
Oakville, Ontario, Canada, L6J 7W5