← Back to Search

Antifungal Agent

DBI-001 for Fungal Nail Infection

Phase 2
Waitlist Available
Research Sponsored by DermBiont, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks of participation
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks of participation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks of participation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in signs and symptoms of Onychomycosis
Secondary outcome measures
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)
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: DBI-002 GelExperimental Treatment1 Intervention
Topical application of DBI-002 gel on foot/feet affected with onychomycosis.
Group II: DBI-001 GelExperimental Treatment1 Intervention
Topical application of DBI-001 gel on foot/feet affected with onychomycosis.
Group III: Aqueous GelPlacebo Group1 Intervention
Topical application of aqueous gel on foot/feet affected with onychomycosis.

Find a Location

Who is running the clinical trial?

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Onychomycosis
2023. "A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Onychomycosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05491603.
~40 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top