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

Phase 2

Completed

• Conditions: Tinea Pedis
• Interventions: Drug: Janthinobacterium lividum

• Registration Number: NCT04152226
• Lead Sponsor: DermBiont, Inc.

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.

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.

Study Timeline

• Study Start: 2019-02-19
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2019-11-01
• Study First Posted: 2019-11-05
• Results First Submitted: 2023-10-11
• Status Verified: 2025-04
• Results First Submitted QC: 2025-06-13
• Last Update Submitted: 2025-06-13
• Results First Posted: 2025-06-17
• Last Update Posted: 2025-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Subjects with the following will be excluded from this study:

1. Any dermatological conditions that could interfere with clinical evaluations.
2. Any underlying disease(s) or some other dermatological condition that requires the use of interfering topical or systemic therapy.
3. 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
4. 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
5. Treatment of any type of cancer within the last 6 months.
6. History of any significant internal disease (which contraindicates use of live microbiome e.g. leukemia, liver failure, cardiovascular disease)
7. 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.
8. AIDS or AIDS related complex by medical history.
9. Known or suspected immune suppressive medications or diseases.
10. Diabetes mellitus Type I or II by medical history.
11. Peripheral vascular disease based on medical history.
12. Any subject not able to meet the study attendance requirements.
13. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1	Janthinobacterium lividum	Cohort 1 DBI-001 Gel with 10\^6 CFUs/ml of J.lividum
Cohort 2	Janthinobacterium lividum	Cohort 2 DBI-001 Gel with 10\^7 CFUs/ml of J.lividum
Cohort 3	Janthinobacterium lividum	Cohort 3 DBI-001 Gel with 10\^8 CFUs/ml of J.lividum

Primary Outcome Measures

Name	Time	Method
Safety Evaluation Cohort 1	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	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	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

Trial Locations

Locations (1)

Instituto Dermatologico y Cirugia de Piel; 🇩🇴 Santo Domingo, Dominican Republic