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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
24
Topical application of DBI-001 gel on foot/feet affected with tinea pedis
Topical application of DBI-002 gel on foot/feet affected with tinea pedis
Topical application of Aqueous gel on foot/feet affected with tinea pedis
Oregon Dermatology and Research
Portland, Oregon, United States
Premier Clinical Research
Spokane, Washington, United States
Change in abundance of T. rubrum based on Quantitative Polymerase Chain Reaction (qPCR)
Change in abundance of T. rubrum at baseline, day 7 and day 14
Time frame: 14 days of participation
Number of participants with treatment-related adverse events
Safety
Time frame: 14 days of participation
Changes in signs and symptoms of T. Pedis
Change from baseline in individual signs and symptoms of Tinea Pedis at days 7 and 14 of sites treated with DBI-001 Gel, DBI-002 Gel, or Aqueous Gel. The minimum value is 0 and the maximum value is 3 the subject's self reported observation on local tolerability.
Time frame: 14 days of participation
Changes in the signs and symptoms and Investigators Static Global Assessment (ISGA) of Tinea Pedis
Changes from Baseline in signs and symptoms and ISGA at Days 7 and 14
Time frame: 14 days of participation
Change in abundance of T. rubrum based on qPCR and WGS
Antimicrobial efficacy
Time frame: 14 days of participation
Molecular diagnostic qPCR and WGS comparison of DBI-001 Gel, DBI-002 Gel and Aqueous Gel
Antimicrobial efficacy and microbiome community analysis
Time frame: 14 days of participation
Bacterial culture comparison of DBI-001 Gel, DBI-002 Gel and Aqueous Gel
Antimicrobial efficacy and microbiome community analysis
Time frame: 14 days of participation
Increase or decrease of colony forming units after DBI-001 Gel, DBI-002 Gel application
Antimicrobial efficacy
Time frame: 14 days of participation
Correlation between levels of DBI-001 Gel, DBI-002 Gel and abundance of T. rubrum based on qPCR
Antimicrobial efficacy
Time frame: 14 days of participation
Correlation between qPCR quantification and KOH for presence of T. rubrum at screening
Compare sensitivity and specificity of qPCR analysis and KOH for presence of T. rubrum at Screening
Time frame: 28 days from screening
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