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

NCT04152226 | Completed Phase 2 Results

• 1 other identifier: DBI-201
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. In addition, the effect of J. lividum on the T. pedis will also be evaluated.

Conditions

Tinea Pedis

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  28 days

Study Arms (3)

Cohort 1

ACTIVE COMPARATOR

Cohort 1 DBI-001 Gel with 10\^6 CFUs/ml of J.lividum

Drug: Janthinobacterium lividum

Cohort 2

ACTIVE COMPARATOR

Cohort 2 DBI-001 Gel with 10\^7 CFUs/ml of J.lividum

Drug: Janthinobacterium lividum

Cohort 3

ACTIVE COMPARATOR

Cohort 3 DBI-001 Gel with 10\^8 CFUs/ml of J.lividum

Drug: Janthinobacterium lividum

Interventions

Janthinobacterium lividum DRUG

Investigational Product

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• DermBiont, Inc.: lead

Study Sites (1)

Instituto Dermatologico y Cirugia de Piel

Santo Domingo, Dominican Republic

Location

MeSH Terms

Conditions

Tinea Pedis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Foot Dermatoses; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pruritus; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Emma Taylor, MD (Chief Medical Officer)
• Organization: Dermbiont, Inc

emma@dermbiont.com

510-607-8155

Study Officials

• : Daisy Blanco, MD

  Instituto Dermatologico y Cirugia de Piel

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: November 5, 2019
• Study Start: February 19, 2019
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: June 17, 2025
• Results First Posted: June 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DO (1)