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 range18 Years – 65 Years

SexALL

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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.
✓. 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

What they're measuring

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

Timeframe: 14 days of participation

Trial details

NCT IDNCT05493488

SponsorDermBiont, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-31

View on ClinicalTrials.gov More Tinea Pedis trials