DBI-001 Gel for Tinea Pedis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Oregon Dermatology and Research, Portland, OR
Tinea Pedis+1 More
DBI-001 Gel - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the effect of two different gels on athletes foot, comparing DNA sequencing and a standard lab test to see which is more accurate, and looking at side effects of the gel. DBI-001 Gel is a treatment for Tinea Pedis that can be completed online.

Eligible Conditions

  • Tinea Pedis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Tinea Pedis

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: 28 days from screening

14 days of participation
Bacterial culture comparison of DBI-001 Gel, DBI-002 Gel and Aqueous Gel
Change in abundance of T. rubrum based on Quantitative Polymerase Chain Reaction (qPCR)
Change in abundance of T. rubrum based on qPCR and WGS
Changes in signs and symptoms of T. Pedis
Changes in the signs and symptoms and Investigators Static Global Assessment (ISGA) of Tinea Pedis
Correlation between levels of DBI-001 Gel, DBI-002 Gel and abundance of T. rubrum based on qPCR
Increase or decrease of colony forming units after DBI-001 Gel, DBI-002 Gel application
Molecular diagnostic qPCR and WGS comparison of DBI-001 Gel, DBI-002 Gel and Aqueous Gel
Number of participants with treatment-related adverse events
28 days from screening
Correlation between qPCR quantification and KOH for presence of T. rubrum at screening

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Tinea Pedis

Trial Design

3 Treatment Groups

DBI-001 Gel
1 of 3
DBI-002 Gel
1 of 3
Aqueous Gel
1 of 3
Active Control
Non-Treatment Group

24 Total Participants · 3 Treatment Groups

Primary Treatment: DBI-001 Gel · Has Placebo Group · Phase 2

DBI-001 Gel
Biological
ActiveComparator Group · 1 Intervention: DBI-001 Gel · Intervention Types: Biological
DBI-002 Gel
Biological
ActiveComparator Group · 1 Intervention: DBI-002 Gel · Intervention Types: Biological
Aqueous Gel
Biological
PlaceboComparator Group · 1 Intervention: Aqueous Gel · Intervention Types: Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 28 days from screening
Closest Location: Oregon Dermatology and Research · Portland, OR
Photo of Portland 1Photo of Portland 2Photo of Portland 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Tinea Pedis
0 CompletedClinical Trials

Who is running the clinical trial?

DermBiont, Inc.Lead Sponsor
9 Previous Clinical Trials
431 Total Patients Enrolled
2 Trials studying Tinea Pedis
51 Patients Enrolled for Tinea Pedis
Emma Taylor, Ph.DStudy DirectorDermBiont, Inc.

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are of any race.
Subjects with a clinical diagnosis of interdigital T
You have a quantifiable level of T.
The web space should have sufficient scale sampling for KOH.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.