A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subje… (NCT05493488) | Clinical Trial Compass
UnknownPhase 2
A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Tinea Pedis
United States24 participantsStarted 2022-09-08
Plain-language summary
This is a randomized, observer blinded, Aqueous Gel-controlled trial examining the effect of daily application for approximately 6-8 days of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel on the subjects with interdigital tinea pedis based on Whole Genome Sequencing (WGS) and Quantitative Polymerase Chain Reaction (qPCR), and comparison between Quantitative Polymerase Chain Reaction (qPCR) and Potassium Hydroxide (KOH) for the presence of Trichophyton rubrum (T.rubrum) as well as signs and symptoms and local tolerability and toxicity on treated sites in subjects.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Ability to understand, agree to, and sign the study Informed Consent
. A signed Health Information Portability and Accountability Act (HIPAA) authorization form which permits the use and disclosure of the subject's individually identifiable health information.
. Male or Female Subjects of any race 18-65 years of age.
. Subjects with a clinical diagnosis of interdigital T. pedis.
. Investigator confirmed diagnosis by a positive T. rubrum potassium hydroxide (KOH) wet mount at Screening at the investigative site.
. A quantifiable level of T. rubrum based on Sponsor laboratory qPCR from the sample obtained at the Screening visit.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in abundance of T. rubrum based on Quantitative Polymerase Chain Reaction (qPCR)
. The sum of the clinical signs and symptoms scores of at least one web space (Target web space) is at least 4 using the Grading of Signs and Symptoms of T. pedis including a minimum score of 2 for erythema AND a minimum score of 2 for either scaling/fissures or pruritus/burning (on a scale of 0-3, where 2 indicates moderate severity).
. Target web space(s) should have an adequate amount of leading-edge scale to provide enough scale sampling for KOH.
Exclusion criteria
. Women who are pregnant, planning a pregnancy, breastfeeding or have a positive pregnancy test at screening.
. Any dermatological conditions that could interfere with clinical evaluations
. The clinical diagnosis of moccasin T. pedis.
. Subjects with gram negative interdigital tinea pedis based on a clinical diagnosis: Gram-negative athlete's foot - the interspace is foul smelling, whitish, painful, strongly macerated, and hyperkeratotic with erosions, exudation, and intense inflammation and often disabling.
. Any underlying disease(s) or other dermatological condition that requires the use of interfering topical or systemic therapy.
. Subjects with concurrent use of any of the following topical preparations who have not completed the specified washout period(s) for the following topical medications applied to the foot at the time of the Screening visit:
. Washout of 1 week prior to the screening visit for topical astringents and abrasives (e.g., Burrow's solution), Vicks VapoRub, tea tree oil)
. Washout of 2 weeks prior to the screening visit for topical antibiotics and antifungal on the feet (e.g., Neomycin, Miconazole, Clotrimazole, Terbinafine)