Completed PHASE3 INTERVENTIONAL 8-arm NCT02007434

Patient Experience Study of Deoxycholic Acid Injection

A Single Center, Double-blind, Parallel-group, Two Factor Patient-Experience Management Study of ATX-101 (Deoxycholic Acid Injection) for the Reduction of Localized Subcutaneous Fat in the Submental Area

Sponsor: Kythera Biopharmaceuticals

Conditions Moderate or Severe Submental Fullness

Interventions Cold Compress Compression Chin Strap Deoxycholic Acid Injection Ibuprofen Lidocaine / Epinephrine Loratadine Placebo

Updated 6 times since 2017 Last updated: Jul 6, 2015 Started: Dec 31, 2013 Primary completion: Jun 30, 2014 Completion: Jun 30, 2014

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02007434, this PHASE3 trial focuses on Moderate or Severe Submental Fullness and remains completed. Sponsored by Kythera Biopharmaceuticals, it has been updated 6 times since 2013, reflecting limited change activity. Mental health research at this phase helps define safety and dosing parameters for future study.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Feb 2017 — Jun 2018 [monthly]

Completed PHASE3

▶ Show 1 earlier version

Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Dec 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Kythera Biopharmaceuticals

Data source: Kythera Biopharmaceuticals

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Tempe, United States