Phase 3 Study of Deoxycholic Acid Injection (ATX-101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area — REFINE-1

Moderate or Severe Submental Fullness Clinical Trial

Official title:
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ATX-101 (Sodium Deoxycholate Injection) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area

Status Completed

Clinical Trial Summary

To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Moderate or Severe Submental Fullness

Clinical Trial Details

NCT number	NCT01542034
Study type	Interventional
Source	Kythera Biopharmaceuticals
Contact
Status	Completed
Phase	Phase 3
Start date	February 2012
Completion date	August 2013

View Details

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	`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	`NCT01426373` - Open-Label Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area	Phase 3
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