A Phase 2 interventional study of DBI-001 Gel and DBI-002 Gel in Tinea Pedis, sponsored by DermBiont, Inc.. Status unknown at 2 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-14.
Sponsored by DermBiont, Inc. · Phase 2, Interventional, and Treatment
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.
73 studies on the registry are indexed under Tinea Pedis; 8 are open to participants now.
This study's planned enrollment of 24 is below the median of 128 across 66 interventional studies indexed under Tinea Pedis.
Browse Tinea Pedis studies →DermBiont, Inc. is the lead sponsor of 13 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects with concurrent use of any of the following topical preparations who have not completed the specified (s) for the following topical medications applied to the foot at the time of the Screening visit:
Subjects with concurrent use of any of the following systemic medications who have not completed the specified washout period(s) for the following systemic medications at the time of the Screening visit:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Topical application of DBI-001 Gel on foot/feet affected with tinea pedis
Biological: DBI-001 Gel
Topical application of DBI-002 Gel on foot/feet affected with tinea pedis
Biological: DBI-002 Gel
Topical application of Aqueous Gel on foot/feet affected with tinea pedis
Biological: Aqueous Gel
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
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
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: DBI-001 · DBI-002
DermBiont, Inc.