Other Clinical Trial - Open-Label Study of Deoxycholic Acid for

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Status Completed

Clinical Trial Summary

To evaluate the safety of deoxycholic acid subcutaneous injections in the submental area (below the chin).

n/a

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

NCT number	NCT01426373
Study type	Interventional
Source	Kythera Biopharmaceuticals
Contact
Status	Completed
Phase	Phase 3
Start date	August 2011
Completion date	June 2013

See also
Status	Clinical Trial	Phase
Completed	`NCT01546142` - Phase 3 Study of Deoxycholic Acid Injection (ATX-101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area	Phase 3
Completed	`NCT05266729` - Determine the Dosing Interval and Optimal Dose of AYP-101 for the Reduction of Submental Fat in Chin Area	Phase 2
Completed	`NCT03982225` - Evaluate the Efficacy and Safety of Polyene Phosphatidylcholine Injection (AYP-101) for the Reduction of Submental Fat	Phase 2
Completed	`NCT01294644` - Evaluation of Safety and Efficacy of Deoxycholic Acid Injection (ATX-101) in the Reduction of Submental Fat	Phase 3
Completed	`NCT01542034` - Phase 3 Study of Deoxycholic Acid Injection (ATX-101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area	Phase 3
Completed	`NCT02007434` - Patient Experience Study of Deoxycholic Acid Injection	Phase 3
Completed	`NCT01305577` - Evaluation of Safety and Efficacy of Deoxycholic Acid Injection (ATX-101) in the Reduction of Submental Fat	Phase 3
Completed	`NCT01032889` - Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study	Phase 2
Completed	`NCT00618722` - Phase 1-2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat	Phase 1/Phase 2
Completed	`NCT00618618` - Phase 2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat	Phase 2