Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06509438
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-13
Brief Title:
Effectiveness and Safety Evaluation of Embella Deoxycholic Acid by Espad Pharmed Co in Management of Submental Fat
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluating the Effectiveness and Safety of Embella Deoxycholic Acid Produced by Espad Pharmed Co for the Management of Submental Fat
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Submental fat SMF is a factor affecting beauty that makes people feel uncomfortable about themselves In 2015 deoxycholic acid with the brand name KYBELLA was approved by the American FDA for treatment of submental fat The purpose of this study is to evaluate the safety and effectiveness of deoxycholic acid injection with the brand name Embella manufactured by Espad Pharmed Company for treatment of this condition
Research Objectives
Primary objective
Effectiveness and safety of Embella in reducing submental fat
Secondary objective
Effectiveness assessment of Embella in improving SMF grading Effectiveness assessment of Embella in reducing submental fat diameter
Research Objectives
Primary objective
Effectiveness and safety of Embella in reducing submental fat
Secondary objective
Effectiveness assessment of Embella in improving SMF grading Effectiveness assessment of Embella in reducing submental fat diameter
Detailed Description:
None
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