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Antifungal Agent

Antifungal Gels for Athlete's Foot

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 older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days from screening

Awards & highlights

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.

Who is the study for?

This trial is for adults aged 18-65 with athlete's foot caused by T. rubrum, confirmed through lab tests and symptoms. Participants must understand and sign consent forms, including HIPAA authorization. Excluded are those with recent cancer treatment (except certain skin cancers), significant diseases, allergies to study gels, immune suppression, pregnancy/breastfeeding, other dermatological conditions or treatments that could affect results.Check my eligibility

What is being tested?

The trial compares the safety and effectiveness of two experimental gels (DBI-001 Gel and DBI-002 Gel) against an Aqueous Gel in treating athlete's foot over a period of about a week. It uses DNA sequencing and PCR testing to measure the presence of fungus before and after treatment.See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones for topical antifungal treatments include local irritation like redness or itching at the application site. There may also be risks related to allergic reactions if sensitivity to gel components exists.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days from screening

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days from screening

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days from screening for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in abundance of T. rubrum based on Quantitative Polymerase Chain Reaction (qPCR)

Secondary outcome measures

Bacterial culture comparison of DBI-001 Gel, DBI-002 Gel and Aqueous Gel

Change in abundance of T. rubrum based on qPCR and WGS

Changes in signs and symptoms of T. Pedis

+6 more

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: DBI-002 GelActive Control1 Intervention

Topical application of DBI-002 Gel on foot/feet affected with tinea pedis

Group II: DBI-001 GelActive Control1 Intervention

Topical application of DBI-001 Gel on foot/feet affected with tinea pedis

Group III: Aqueous GelPlacebo Group1 Intervention

Topical application of Aqueous Gel on foot/feet affected with tinea pedis

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

DermBiont, Inc.Lead Sponsor

11 Previous Clinical Trials

529 Total Patients Enrolled

Emma Taylor, Ph.DStudy DirectorDermBiont, Inc.

Media Library

DBI-001 Gel (Antifungal Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05493488 — Phase 2

Athlete's Foot Research Study Groups: Aqueous Gel, DBI-002 Gel, DBI-001 Gel

Athlete's Foot Clinical Trial 2023: DBI-001 Gel Highlights & Side Effects. Trial Name: NCT05493488 — Phase 2

DBI-001 Gel (Antifungal Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05493488 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is admittance for this research limited to those over twenty years of age?

"According to the guidelines for inclusion, participants of this medical trial must be between eighteen and sixty-five years old."

Answered by AI

Are there opportunities to enroll in the current study?

"Based on the information from clinicaltrials.gov, this particular investigation is not accepting applicants at present. Initially posted in September 8th 2022 and last modified on September 19th 2022, there are still 3 other trials which require participants to join them immediately."

Answered by AI

What has been revealed about the potential hazards of utilizing DBI-001 Gel?

"After careful consideration, our team assigned a score of 2 to DBI-001 Gel's safety levels due to the Phase 2 trial results. While there is evidence demonstrating its backing in terms of security, there are no studies that support its efficacy as yet."

Answered by AI

Who has the opportunity to participate in this medical experiment?

"This trial is looking for 24 people aged between 18 and 65 who currently have tinea pedis. Participants must meet additional criteria including being able to understand the informed consent, signing a HIPAA authorization form allowing use of their health information, providing laboratory evidence confirming infection with T rubrum, possessing at least one web space showing moderate erythema and either scaling/fissures or pruritus/burning according to the Grading of Signs and Symptoms of T pedis scale, as well as having enough leading-edge scale to provide sample materials for KOH testing."

Answered by AI

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 Tinea Pedis

2022. "A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Tinea Pedis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05493488.