NCT05491603

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

Name: Clinical Trial NCT05491603
Creator: DermBiont, Inc.
Keywords: Onychomycosis, DBI-001, Phase 2, biological, clinical trial, United States of America

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

DermBiont, Inc.·Phase 2·ClinicalTrials.gov·biologicalSuspended

View on ClinicalTrials.gov →

Study focus

Disease/Condition: Onychomycosis
Drug/Device/Intervention: DBI-001
Study type: Interventional
Intervention type: biological

Sponsor & location

Primary sponsor: DermBiont, Inc.
Location: Encino,New Brighton,Portland,Austin,Mill Creek, United States of America

Timeline & enrollment

Phase: Phase 2
Start date: Oct 01, 2022
End date: Nov 30, 2023
Enrollment: 60 participants

Primary outcome

Change in percentage of involved great toenail(s),Changes in signs and symptoms of Onychomycosis

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.

ICD-10 classifications

OnychogryphosisChromomycosis, unspecifiedOnycholysisActinomycosisBlastomycosis

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05491603
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT05491603 through Pure Global AI's free database. This Phase 2 trial is sponsored by DermBiont, Inc. and is currently Suspended. The study focuses on Onychomycosis. Target enrollment is 60 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.