ClinicalTrials.gg
Status unknownNCT05493488Updated Feb 14, 2023

A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Tinea Pedis

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

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Tinea Pedis

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03

In context

Tinea Pedis

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 →

Lead sponsor

DermBiont, Inc. is the lead sponsor of 13 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  1. Ability to understand, agree to, and sign the study
  2. 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.
  3. Male or Female Subjects of any race 18-65 years of age.
  4. Subjects with a clinical diagnosis of interdigital T. pedis.
  5. Investigator confirmed diagnosis by a positive T. rubrum potassium hydroxide (KOH) wet mount at Screening at the investigative site.
  6. A quantifiable level of T. rubrum based on Sponsor laboratory qPCR from the sample obtained at the Screening visit.
  7. 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).
  8. Target web space(s) should have an adequate amount of leading-edge scale to provide enough scale sampling for KOH.

Exclusion criteria

Exclusion Criteria:

  1. Women who are pregnant, planning a pregnancy, breastfeeding or have a positive pregnancy test at screening.
  2. Any dermatological conditions that could interfere with clinical evaluations
  3. The clinical diagnosis of moccasin T. pedis.
  4. 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.
  5. Any underlying disease(s) or other dermatological condition that requires the use of interfering topical or systemic therapy.
  6. 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:

    1. Washout of 1 week prior to the screening visit for topical astringents and abrasives (e.g., Burrow's solution), Vicks VapoRub, tea tree oil)
    2. Washout of 2 weeks prior to the screening visit for topical antibiotics and antifungal on the feet (e.g., Neomycin, Miconazole, Clotrimazole, Terbinafine)
    3. Washout of 4 weeks prior to the screening visit for the topical Anti-inflammatories, , topical immunomodulators on the feet (e.g., Pimecrolimus, Tacrolimus)
  7. 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:

    1. Washout of 4 weeks prior to the screening visit for the systemic corticosteroids (including intramuscular injections) (e.g., Triamcinolone acetonide)
    2. Washout of 4 weeks prior to the screening visit for the systemic antibiotics (e.g., Tetracycline, Cephalosporins, etc.) and/or Antifungal agents (e.g., Fluconazole, Itraconazole, Terbinafine, etc.)
    3. Washout of 4 weeks prior to the screening visit for the systemic immunomodulators (e.g., Cyclophosphamide, Azathioprine, Biologicals-Monoclonal Antibodies)
  8. Treatment of any type of cancer within the last 6 months except for superficial skin cancers such as basal cell carcinoma and squamous cell carcinoma.
  9. History of any significant internal disease which contraindicates use of a live microbiome (e.g., leukemia, liver failure, cardiovascular disease).
  10. Subjects who are known to be allergic to any of the Test article(s) or any components in the test article(s) or history of or allergic reactions to any of the study preparations as described in the Investigator's Brochure.
  11. AIDS or AIDS related complex by medical history.
  12. History of current street drug or alcohol abuse, or street drug or alcohol abuse within the past year.
  13. Known or suspected immune suppressive medications or diseases.
  14. Subjects with poorly controlled diabetes mellitus Type I or II requiring medical intervention/treatment.
  15. Peripheral vascular disease based on medical history.
  16. Any subject not able to meet the study attendance requirements.
  17. Subjects who have participated in any other trial of an drug or device within 30 days prior to enrollment or participation in a research study concurrent with this study.
  18. Use of any orthopedic appliance (e.g., cast, soft cast, splint) on either foot or ankle, or surgery of either foot or ankle within 90 days of the Screening visit.
Terms in these criteria, in plain language(5)

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.

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.

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.

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.

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.

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • Active comparator
    DBI-001 Gel

    Topical application of DBI-001 Gel on foot/feet affected with tinea pedis

    Biological: DBI-001 Gel

  • Active comparator
    DBI-002 Gel

    Topical application of DBI-002 Gel on foot/feet affected with tinea pedis

    Biological: DBI-002 Gel

  • Placebo comparator
    Aqueous Gel

    Topical application of Aqueous Gel on foot/feet affected with tinea pedis

    Biological: Aqueous Gel

Interventions

  • BiologicalDBI-001 Gel

    Topical application of DBI-001 gel on foot/feet affected with tinea pedis

  • BiologicalDBI-002 Gel

    Topical application of DBI-002 gel on foot/feet affected with tinea pedis

  • BiologicalAqueous Gel

    Topical application of Aqueous gel on foot/feet affected with tinea pedis

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of participants with treatment-related adverse events

    Safety

    Time frame: 14 days of participation

  2. 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

  3. 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

  4. Change in abundance of T. rubrum based on qPCR and WGS

    Antimicrobial efficacy

    Time frame: 14 days of participation

  5. 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

  6. 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

  7. Increase or decrease of colony forming units after DBI-001 Gel, DBI-002 Gel application

    Antimicrobial efficacy

    Time frame: 14 days of participation

  8. 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

  9. 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

07

Study locations

2 sites
  • Oregon Dermatology and Research
    Portland, Oregon 97210, United States
  • Premier Clinical Research
    Spokane, Washington 99202, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05493488
Lead sponsor
DermBiont, Inc.
Responsible party
Sponsor
First posted
Aug 9, 2022
Start date
Sep 8, 2022
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Feb 14, 2023

Study contacts

Emma Taylor, Ph.D
study director · DermBiont, Inc.

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: DBI-001 · DBI-002

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