Your session is about to expire
← Back to Search
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
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.
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.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in abundance of T. rubrum based on Quantitative Polymerase Chain Reaction (qPCR)
Secondary study objectives
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 moreTrial 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
Find a Location
Who is running the clinical trial?
DermBiont, Inc.Lead Sponsor
13 Previous Clinical Trials
717 Total Patients Enrolled
Emma Taylor, Ph.DStudy DirectorDermBiont, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a skin condition that needs treatment that could interfere with the study.You have had any type of cancer treatment in the last 6 months, except for superficial skin cancers like basal cell carcinoma and squamous cell carcinoma.You have had surgery on your foot or ankle or are currently using a cast, soft cast, or splint on your foot or ankle within the last 90 days.You have a measurable amount of T. rubrum in the sample taken during the screening visit, as determined by the Sponsor's laboratory testing.You are taking medications that weaken your immune system or have a condition that weakens your immune system.You have a history of AIDS or AIDS-related complex.The doctor confirmed the diagnosis using a special test for a fungus called T. rubrum.You have skin conditions that could affect the study's skin evaluations.You have been diagnosed with a specific type of foot fungus called moccasin T. pedis.You have a severe type of athlete's foot that is causing a lot of discomfort and has specific symptoms like bad smell, whitish color, pain, and intense inflammation.You have diabetes that is not well managed and needs medical treatment.You have a history of peripheral vascular disease.You have been diagnosed with athlete's foot between your toes.You have a certain level of redness, scaling, or itching between your toes, as determined by a scoring system.Criterion: The target area should have enough skin cells for testing.You have used illegal drugs or abused alcohol in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: Aqueous Gel
- Group 2: DBI-002 Gel
- Group 3: DBI-001 Gel
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger