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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 Tinea Pedis

NCT05493488 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-02-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • DermBiont, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-08
Primary Completion
2023-12-31
Completion
2023-12-31
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 NCT05493488 on ClinicalTrials.gov