Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422188
Status:
COMPLETED
Last Update Posted:
2015-12-10
First Post:
2007-01-11
Brief Title:
Deoxycholic Acid Injection for the Treatment of Superficial Lipomas
Sponsor:
Kythera Biopharmaceuticals
Organization:
Kythera Biopharmaceuticals
Study Overview
Official Title:
Phase 1 Multicenter Randomized Double-Blind Placebo-Controlled Sequential Dose-Escalation Study of the Pharmacokinetics Safety and Efficacy of ATX-101 Sodium Deoxycholate for Injection Intralipomal Injections for the Treatment of Superficial Lipomas
Status:
COMPLETED
Status Verified Date:
2015-12
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 purpose of this research is to compare the safety and effectiveness of 4 different concentrations of deoxycholic acid injection against a placebo in the treatment of superficial lipomas
Detailed Description:
A lipoma is a fatty lump typically located on the trunk shoulder arms or legs For the purposes of this study only lipomas on the trunk arms legs or neck were treated Lipomas on the face wrists hands lower portion of the spine genitals ankles or feet were not treated
Study Oversight
Has Oversight DMC:
None
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?:
None