Clinical Trials Directory

Trials / Completed

CompletedNCT00618618

Phase 2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat

Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Safety and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Given by Three Dosing Paradigms for the Reduction of Localized Subcutaneous Fat in the Submental Area

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
73 (actual)
Sponsor
Kythera Biopharmaceuticals · Industry
Sex
All
Age
25 Years – 65 Years
Healthy volunteers
Not accepted

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 (fat beneath the chin).

Conditions

Interventions

TypeNameDescription
DRUGDeoxycholic Acid InjectionFormulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
DRUGPlacebo

Timeline

Start date
2008-04-01
Primary completion
2008-12-01
Completion
2008-12-01
First posted
2008-02-20
Last updated
2015-07-14
Results posted
2015-06-15

Locations

7 sites across 3 countries: Australia, Canada, United Kingdom

Source: ClinicalTrials.gov record NCT00618618. Inclusion in this directory is not an endorsement.