Ignite Creation Date:
2024-05-06 @ 5:57 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05493488
Status:
UNKNOWN
Last Update Posted:
2023-02-14
First Post:
2022-07-26
Brief Title:
A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel DBI-002 Gel and Aqueous Gel in Subjects With Tinea Pedis
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 Interdigital Tinea Pedis
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
This is a randomized observer blinded Aqueous Gel-controlled trial examining the effect of daily application for approximately 6-8 days of DBI-001 Gel DBI-002 Gel and Aqueous Gel on the subjects with interdigital tinea pedis based on Whole Genome Sequencing WGS and Quantitative Polymerase Chain Reaction qPCR and comparison between Quantitative Polymerase Chain Reaction qPCR and Potassium Hydroxide KOH for the presence of Trichophyton rubrum Trubrum as well as signs and symptoms and local tolerability and toxicity on treated sites in subjects
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