Ignite Creation Date:
2024-05-06 @ 5:58 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05491603
Status:
SUSPENDED
Last Update Posted:
2023-09-07
First Post:
2022-07-28
Brief Title:
A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel DBI-002 Gel and Aqueous Gel in Subjects With Onychomycosis
Sponsor:
DermBiont Inc
Organization:
DermBiont Inc
Study Overview
Official Title:
An Observer-Blinded Randomized Aqueous Gel-Controlled Trial of the Safety and Efficacy of DBI-001 Gel DBI-002 Gel and Aqueous Gel in Subjects With Onychomycosis
Status:
SUSPENDED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Suspended Study halted prematurely but potentially will resume Sponsor suspension and not due to safety or site-related matters
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized observer-blinded Aqueous Gel-controlled trial examining the safety and efficacy of daily application of DBI-001 Gel vs DBI-002 Gel vs Aqueous Gel for 24 consecutive weeks in subjects with onychomycosis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None