Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-03 @ 10:56 PM
Study NCT ID:
NCT01876550
Status:
COMPLETED
Last Update Posted:
2019-05-09
First Post:
2013-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Bioequivalence of Mupirocin Calcium Cream, 2% and Bactroban® Cream and Compare Both to a Vehicle in Treatment of Secondarily Infected Traumatic Skin Lesions.
Sponsor:
Sun Pharmaceutical Industries, Inc.
Organization:
Study Overview
Official Title:
A Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled, Multicenter Study to Evaluate the Safety and Bioequivalence of a Generic Mupirocin Calcium Cream, 2% and Reference Listed Bactroban® Cream (Mupirocin Calcium Cream, 2%) and Compare Both Active Treatments to a Vehicle Control in the Treatment of Secondarily Infected Traumatic Skin Lesions.
Status:
COMPLETED
Status Verified Date:
2019-05
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 primary objective of this study is to determine the comparability of the safety and efficacy of Mupirocin Calcium Cream, 2% and Bactroban® Cream in subjects with secondarily infected traumatic skin lesions. It will also be determined whether the efficacy of each of the active treatments is superior to that of the vehicle cream (placebo).
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?: