Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-04-10 @ 12:20 AM
Study NCT ID:
NCT02035267
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2014-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety Study of ATX-101 (Deoxycholic Acid) in Subjects With Mild or Extreme Fullness of Submental Fat
Sponsor:
Kythera Biopharmaceuticals
Organization:
Study Overview
Official Title:
A Multicenter, Double-blind, Placebo-controlled Safety Study of ATX-101 (Deoxycholic Acid) Injection for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects With Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Grade 1 or CR-SMFRS Grade 4
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objectives of this study are to explore the safety and efficacy of subcutaneous injections of Deoxycholic Acid relative to placebo, in the submental area in patients with mild or extreme fullness of the submental fat and ratings of 1 or 4.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: