DBI-001 for Onychomycosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
North Sound Dermatology, Mill Creek, WA
Onychomycosis
DBI-001 - Biological
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Onychomycosis

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: 48 weeks of participation

48 weeks of participation
Change in Investigator's Static Global Assessment (ISGA)
Change in colony forming units after using DBI-001 Gel or DBI-002 Gel or Aqueous Gel at Weeks 24 and 48
Change in percentage of involved great toenail(s)
Evaluate the effect of DBI-001 Gel and DBI-002 Gel on the change in relative abundance and diversity of the cutaneous microbiome of the great toenail(s) from Screening to Weeks 24 and 48 as measured by WGS
Evaluate the presence of DBI-001, DBI-002 based on qPCR and WGS and Weeks 24 and 48
Length of new clear nail growth
Molecular diagnostic quantitative polymerase chain reaction (qPCR) and whole genome sequencing (WGS) comparison of DBI-001 Gel, DBI-002 Gel and Aqueous Gel on the impact of T. rubrum levels
Population with completely clear nail growth
Week 48
Changes in signs and symptoms of Onychomycosis

Trial Safety

Safety Progress

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

Other trials for Onychomycosis

Trial Design

3 Treatment Groups

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

60 Total Participants · 3 Treatment Groups

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

DBI-002 Gel
Biological
Experimental Group · 1 Intervention: DBI-002 · Intervention Types: Biological
DBI-001 Gel
Biological
Experimental Group · 1 Intervention: DBI-001 · 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: 48 weeks of participation
Closest Location: North Sound Dermatology · Mill Creek, WA
Photo of washington 1Photo of washington 2Photo of washington 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Onychomycosis
0 CompletedClinical Trials

Who is running the clinical trial?

DermBiont, Inc.Lead Sponsor
9 Previous Clinical Trials
395 Total Patients Enrolled
Emma Taylor, M.D.Study DirectorDermBiont, Inc.

Eligibility Criteria

Age 18 - 65 · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are 18 to 50 years of age, inclusive, at Screening.
You are willing to abstain from all cosmetic activities involving the toenails during the entire course of the study.
You are willing to have your great toenail(s) clipped at each visit.
You have been screened for microorganisms of interest by qPCR and 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.