Tinea PedisPhase 2NCT04152226

A Trial to Evaluate the Safety and and Tolerability of DBI-001 in Patients With Tinea Pedis

A Phase 2 study testing Janthinobacterium lividum in people with Tinea Pedis, run by DermBiont, Inc. at 1 site in Dominican Republic.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is an open-label, single-dose, dose escalating evaluation of the safety and tolerability of three dose levels of DBI-001 in patients with Tinea pedis. The purpose of the current protocol is to establish the safety and tolerability of a single application of J. lividum to the feet of patients with proven T. pedis. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Tinea Pedis
What is being tested?: Janthinobacterium lividum
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteDominican Republic
Study dates: 19 Feb 2019to 30 Apr 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

Subjects with the following will be excluded from this study:
Any dermatological conditions that could interfere with clinical evaluations.
Any underlying disease(s) or some other dermatological condition that requires the use of interfering topical or systemic therapy.
Subjects that have not undergone the specified washout period(s) for the following topical preparations or subjects who require the concurrent use of any of the following topical medications applied to the foot: Topical astringents and abrasives (e.g. Burrow's solution) 1 week Topical antibiotics and antifungal on the infected area (e.g. Neomycin, Miconazole, Clotrimazole, Terbinafine) 2 weeks Anti-inflammatories, corticosteroids, topical immunomodulators (e.g. Pimecrolimus, Tacrolimus) 4 weeks
Subjects that have not undergone the specified washout period(s) for the following systemic medications or subjects who require the concurrent use of any of the following systemic medications: Corticosteroids (including intramuscular injections) (e.g. Triamcinolone acetonide) 4 weeks Antibiotics (e.g. Tetracycline, Cephalosporins, etc.) and/or Antifungal agents (e.g. Fluconazole, Itraconazole, Terbinafine, etc.) 4 weeks Systemic immunomodulators (e.g. Cyclophosphamide, Azathioprine, Biologicals-Monoclonal Antibodies. 4 weeks
Treatment of any type of cancer within the last 6 months.

Show all 14Show fewer

History of any significant internal disease (which contraindicates use of live microbiome e.g. leukemia, liver failure, cardiovascular disease)
Subjects who are known to be allergic to any of the test product(s) or any components in the test product(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure.
AIDS or AIDS related complex by medical history.
Known or suspected immune suppressive medications or diseases.
Diabetes mellitus Type I or II by medical history.
Peripheral vascular disease based on medical history.
Any subject not able to meet the study attendance requirements.
Subjects who have participated in any other trial of an investigational drug or device within 30 days prior to enrollment or participation in a research study concurrent with this study.

Trial locations and contacts

1 site in 1 country.

Dominican Republic1 site

Instituto Dermatologico y Cirugia de Piel
Santo Domingo

Other trials in Dominican Republic

About this study

Official title: Clinical Study Protocol Number DBI-201- Open Label, Single-dose, Dose Escalating Evaluation of the Safety and Tolerability of DBI-001 in Patients With Tinea Pedis

Read the detailed description

Open-label, single-dose, dose escalating evaluation of the safety and tolerability of three dose levels of DBI-001 in patients with Tinea pedis. The test product will be applied by study personnel at the investigational site. Each subject will have a single application of approximately 0.5 ml of the test article applied to each foot. Both affected and unaffected feet will be treated covering the web spaces, toes, toe nails as well as the plantar and lateral aspect of both feet. Each of the three groups will have 4 subjects. After the first cohort has completed their day 7 visits, if no significant tolerability or safety issues identified the second cohort will be enrolled. After the second cohort has completed the day 7 visits and if no significant tolerability of safety issues is identified the third cohort will be enrolled.

Conditions: Tinea Pedis
Being tested: Janthinobacterium lividum
Medical subject headings: Tinea Pedis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Janthinobacterium lividumDrug
Investigational Product

Study groups in NCT04152226
Study group	Role	What they receive
Cohort 1	Active comparator	Cohort 1 DBI-001 Gel with 10^6 CFUs/ml of J.lividum Receives: Drug: Janthinobacterium lividum
Cohort 2	Active comparator	Cohort 2 DBI-001 Gel with 10^7 CFUs/ml of J.lividum Receives: Drug: Janthinobacterium lividum
Cohort 3	Active comparator	Cohort 3 DBI-001 Gel with 10^8 CFUs/ml of J.lividum Receives: Drug: Janthinobacterium lividum

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety Evaluation Cohort 1
Tolerability will be evaluated through assessment of local signs and symptoms. For simplicity, as there were no local tolerability reactions, the cumulative tolerability, inclusive of Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging is represented in the table. Scoring for of each Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging according to the scoring system below. Tolerability events were only considered adverse events if they were grade 3 or higher or required discontinuation of test article or use of conmeds. As no Tolerability events satisfied this criteria, there were no tolerability associated adverse events.
0 = none (complete absence)
1. = mild (slight)
2. = moderate (definitely present)
3. = Severe
Measured: 28 days
Safety Evaluation Cohort 2
Tolerability will be evaluated through assessment of local signs and symptoms. For simplicity, as there were no local tolerability reactions, the cumulative tolerability, inclusive of Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging is represented in the table. Scoring for of each Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging according to the scoring system below. Tolerability events were only considered adverse events if they were grade 3 or higher or required discontinuation of test article or use of conmeds. As no Tolerability events satisfied this criteria, there were no tolerability associated adverse events.
0 = none (complete absence)
1. = mild (slight)
2. = moderate (definitely present)
3. = Severe
Measured: 28 days
Safety Evaluation Cohort 3
Tolerability will be evaluated through assessment of local signs and symptoms. For simplicity, as there were no local tolerability reactions, the cumulative tolerability, inclusive of Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging is represented in the table. Scoring for of each Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging according to the scoring system below. Tolerability events were only considered adverse events if they were grade 3 or higher or required discontinuation of test article or use of conmeds. As no Tolerability events satisfied this criteria, there were no tolerability associated adverse events.
0 = none (complete absence)
1. = mild (slight)
2. = moderate (definitely present)
3. = Severe
Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Feb 201930 Apr 2019

First posted5 Nov 2019
Study start19 Feb 2019
Primary completion30 Apr 2019
Study completion30 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Tinea PedisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: A single center open label dose escalating study design will be used in a population of patients with interdigital Tinea pedis. Each subject will have a single application of the test article applied to each foot. The three test articles will be a low dose, medium and a high dose of J. lividum. Each of the three groups will have 4 subjects. After the first cohort has completed their day 7 visits and if no significant tolerability of safety issues is identified the second cohort will be enrolled. After the second cohort has completed the day 7 visits and if no significant tolerability or safety issues are identified the third cohort will be enrolled. At all evaluations, signs and symptoms of application site reactions will be recorded at baseline, as well as days 2, 3, 7, 14, and 28.
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04152226
Sponsor's protocol ID: DBI-201
Status last verified: Apr 2025
First submitted: 28 Oct 2019
Last updated: 17 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
RecruitingPhase 1
A Phase 1b Study of ZYG24004 in Participants With Tinea Pedis Caused by Dermatophytes
Tinea Pedis
Recruiting
Atmospheric Pressure Cold Plasma for Moderate-to-severe Tinea Pedis
Tinea Pedis
RecruitingPhase 2
Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study
Tinea Pedis
Not yet recruitingObservational study
Sports Nutrition Assessment Program
Diet Habit, Body Weight

All Tinea Pedis trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study Protocol Number DBI-201- Open Label, Single-dose, Dose Escalating Evaluation of the Safety and Tolerability of DBI-001 in Patients With Tinea Pedis
ClinicalTrials.gov ID: NCT04152226
Acronym / sponsor ID: DBI-201
Conditions: Tinea Pedis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: DermBiont, Inc.Industry (pharma, biotech, devices)
Study start: 19 Feb 2019 (actual)
Primary completion: 30 Apr 2019 (actual)
Study completion: 30 Apr 2019 (actual)
First posted: 5 Nov 2019 (actual)
Results: Posted 17 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3
Model description: A single center open label dose escalating study design will be used in a population of patients with interdigital Tinea pedis. Each subject will have a single application of the test article applied to each foot. The three test articles will be a low dose, medium and a high dose of J. lividum. Each of the three groups will have 4 subjects. After the first cohort has completed their day 7 visits and if no significant tolerability of safety issues is identified the second cohort will be enrolled. After the second cohort has completed the day 7 visits and if no significant tolerability or safety issues are identified the third cohort will be enrolled. At all evaluations, signs and symptoms of application site reactions will be recorded at baseline, as well as days 2, 3, 7, 14, and 28.

Arm	Type	Receives
Cohort 1	Active comparator	Drug: Janthinobacterium lividumCohort 1 DBI-001 Gel with 10^6 CFUs/ml of J.lividum
Cohort 2	Active comparator	Drug: Janthinobacterium lividumCohort 2 DBI-001 Gel with 10^7 CFUs/ml of J.lividum
Cohort 3	Active comparator	Drug: Janthinobacterium lividumCohort 3 DBI-001 Gel with 10^8 CFUs/ml of J.lividum

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (14 listed)

Any dermatological conditions that could interfere with clinical evaluations.
Any underlying disease(s) or some other dermatological condition that requires the use of interfering topical or systemic therapy.
Subjects that have not undergone the specified washout period(s) for the following topical preparations or subjects who require the concurrent use of any of the following topical medications applied to the foot: Topical astringents and abrasives (e.g. Burrow's solution) 1 week Topical antibiotics and antifungal on the infected area (e.g. Neomycin, Miconazole, Clotrimazole, Terbinafine) 2 weeks Anti-inflammatories, corticosteroids, topical immunomodulators (e.g. Pimecrolimus, Tacrolimus) 4 weeks
Subjects that have not undergone the specified washout period(s) for the following systemic medications or subjects who require the concurrent use of any of the following systemic medications: Corticosteroids (including intramuscular injections) (e.g. Triamcinolone acetonide) 4 weeks Antibiotics (e.g. Tetracycline, Cephalosporins, etc.) and/or Antifungal agents (e.g. Fluconazole, Itraconazole, Terbinafine, etc.) 4 weeks Systemic immunomodulators (e.g. Cyclophosphamide, Azathioprine, Biologicals-Monoclonal Antibodies. 4 weeks
Treatment of any type of cancer within the last 6 months.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Janthinobacterium lividumInvestigational Product	Drug	Cohort 1, Cohort 2, Cohort 3

Primary outcome

Safety Evaluation Cohort 1
Time frame: 28 days
Tolerability will be evaluated through assessment of local signs and symptoms. For simplicity, as there were no local tolerability reactions, the cumulative tolerability, inclusive of Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging is represented in the table. Scoring for of each Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging according to the scoring system below. Tolerability events were only considered adverse events if they were grade 3 or higher or required discontinuation of test article or use of conmeds. As no Tolerability events satisfied this criteria, there were no tolerability associated adverse events. 0 = none (complete absence) 1. = mild (slight) 2. = moderate (definitely present) 3. = Severe
Safety Evaluation Cohort 2
Time frame: 28 days
Tolerability will be evaluated through assessment of local signs and symptoms. For simplicity, as there were no local tolerability reactions, the cumulative tolerability, inclusive of Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging is represented in the table. Scoring for of each Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging according to the scoring system below. Tolerability events were only considered adverse events if they were grade 3 or higher or required discontinuation of test article or use of conmeds. As no Tolerability events satisfied this criteria, there were no tolerability associated adverse events. 0 = none (complete absence) 1. = mild (slight) 2. = moderate (definitely present) 3. = Severe
Safety Evaluation Cohort 3
Time frame: 28 days
Tolerability will be evaluated through assessment of local signs and symptoms. For simplicity, as there were no local tolerability reactions, the cumulative tolerability, inclusive of Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging is represented in the table. Scoring for of each Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging according to the scoring system below. Tolerability events were only considered adverse events if they were grade 3 or higher or required discontinuation of test article or use of conmeds. As no Tolerability events satisfied this criteria, there were no tolerability associated adverse events. 0 = none (complete absence) 1. = mild (slight) 2. = moderate (definitely present) 3. = Severe

Results and safety

Results posted to the registry on 17 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1	4	4
Cohort 2	4	4
Cohort 3	4	4

Primary outcome: Safety Evaluation Cohort 1

Time frame: 28 days. Count of units. Unit: Feet

Measure	0=None Count n=24 (Percentage) n = 4	1=Mild Count n=24 (Percentage) n = 4	2=Moderate Count n=24 (Percentage) n = 4	3=Severe Count n=24 n = 4
Pruritus Baseline	8	0	0	0
Pruritus 1 Hour Post application	8	0	0	0
Pruritus Day 2	8	0	0	0
Pruritus Day 3	8	0	0	0
Pruritus Day 7	8	0	0	0
Pruritus Day 14	8	0	0	0
Pruritus Day 28	8	0	0	0
Erythema Baseline	8	0	0	0

Population analysed: By number of feet treated

Primary outcome: Safety Evaluation Cohort 2

Time frame: 28 days. Count of units. Unit: Feet

Measure	0=None Count n=24 (Percentage) n = 4	1=Mild Count n=24 (Percentage) n = 4	2=Moderate Count n=24 (Percentage) n = 4	3=Severe Count n=24 n = 4
Pruritus Baseline	8	0	0	0
Pruritus 1 Hour Post application	8	0	0	0
Pruritus Day 2	8	0	0	0
Pruritus Day 3	8	0	0	0
Pruritus Day 7	8	0	0	0
Pruritus Day 14	8	0	0	0
Pruritus Day 28	8	0	0	0
Erythema Baseline	8	0	0	0

Population analysed: By number of feet treated

Primary outcome: Safety Evaluation Cohort 3

Time frame: 28 days. Count of units. Unit: Feet

Measure	0=None Count n=24 (Percentage) n = 4	1=Mild Count n=24 (Percentage) n = 4	2=Moderate Count n=24 (Percentage) n = 4	3=Severe Count n=24 n = 4
Pruritus Baseline	8	0	0	0
Pruritus 1 Hour Post application	8	0	0	0
Pruritus Day 2	8	0	0	0
Pruritus Day 3	8	0	0	0
Pruritus Day 7	8	0	0	0
Pruritus Day 14	8	0	0	0
Pruritus Day 28	8	0	0	0
Erythema Baseline	8	0	0	0

Population analysed: By number of feet treated

Adverse events

Time frame: 28 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Cohort 2	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Cohort 3	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Tinea Pedis

RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
RecruitingPhase 1
A Phase 1b Study of ZYG24004 in Participants With Tinea Pedis Caused by Dermatophytes
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Recruiting
Atmospheric Pressure Cold Plasma for Moderate-to-severe Tinea Pedis
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RecruitingPhase 2
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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

: Daisy Blanco, MD study director

Instituto Dermatologico y Cirugia de Piel

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Janthinobacterium lividum in people with Tinea Pedis, run by DermBiont, Inc. at 1 site in Dominican Republic.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Evaluation Cohort 1 (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04152226.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.