NCT05491603

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: DermBiont, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Onychomycosis

Interventions

Type	Name	Description
BIOLOGICAL	DBI-001	Topically administered
BIOLOGICAL	DBI-002	Topically administered
BIOLOGICAL	Aqueous Gel	Topically administered

Timeline

• Start date: 2023-11-01
• Primary completion: 2023-11-30
• Completion: 2023-11-30
• First posted: 2022-08-08
• Last updated: 2023-09-07

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study