NCT05493488

A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Tinea Pedis

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: DermBiont, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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 (T.rubrum) as well as signs and symptoms and local tolerability and toxicity on treated sites in subjects.

Conditions

• Tinea Pedis

Interventions

Type	Name	Description
BIOLOGICAL	DBI-001 Gel	Topical application of DBI-001 gel on foot/feet affected with tinea pedis
BIOLOGICAL	DBI-002 Gel	Topical application of DBI-002 gel on foot/feet affected with tinea pedis
BIOLOGICAL	Aqueous Gel	Topical application of Aqueous gel on foot/feet affected with tinea pedis

Timeline

• Start date: 2022-09-08
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2022-08-09
• Last updated: 2023-02-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study