Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT04315051
Status:
TERMINATED
Last Update Posted:
2021-06-18
First Post:
2020-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trial of Safety/Efficacy of Test Article in Patients With Interdigital T. Pedis
Sponsor:
DermBiont, Inc.
Organization:
Study Overview
Official Title:
Clinical Trial Protocol DBI-204 Double-Blind, Randomized, Placebo Controlled Trial of the Safety and Efficacy of DBI-001 Gel in Patients With Interdigital Tinea Pedis
Status:
TERMINATED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Covid- 19 has shut the clinic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Placebo Controlled Trial of the Safety and Efficacy of DBI-001 in Patients with Interdigital Tinea pedis (T. pedis)
Detailed Description:
Double-Blind, Randomized, Placebo Controlled Trial of the Safety and Efficacy of DBI-001 Gel in Patients with Interdigital Tinea pedis (T. pedis). The primary objective is to observe the antimicrobial effect of a daily application of DBI-001Gel for 4 weeks in patients with interdigital T. pedis based on the change from culture positive for a dermatophyte to culture negative as determined by routine mycology culture.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
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?: