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

NCT05491603 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-09-07

No results posted yet for this study

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

BIOLOGICAL

DBI-001

Topically administered

BIOLOGICAL

DBI-002

Topically administered

BIOLOGICAL

Aqueous Gel

Topically administered

Sponsors & Collaborators

  • DermBiont, Inc.

    lead INDUSTRY

Principal Investigators

  • Emma Taylor, M.D. · DermBiont, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2023-11-30
Completion
2023-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05491603 on ClinicalTrials.gov