Open Label, Single-dose, Dose Escalating Evaluation of the Safety and Tolerability of DBI-001 in Patients With T. Pedis

Tinea Pedis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04152226
• Other study ID #: DBI-201
• Status: Completed
• Phase: Phase 2
• Start date: February 19, 2019
• Est. completion date: April 30, 2019

Study information

• Verified date: November 2019
• Source: DermBiont, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. In addition, the effect of J liv on the T. pedis will also be evaluated.

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.

Study Objectives and Purpose The purpose of the study is to evaluate the safety and tolerability of DBI-001 in patients with Tinea pedis. Secondly to evaluate presence or persistence of J. lividum of DBI-001 following a single application of DBI-001. Thirdly to see the effect on the abundance of T. rubrum. Lastly to see the effect of a single application of DBI-001 on the signs and symptoms of interdigital T. pedis.

Tolerability will be evaluated through assessment of selected local signs and symptoms (pain / burning / stinging, pruritus, erythema, edema, and scabbing / crusting). Any local skin reaction that requires use of a concomitant therapy or study discontinuation will be reported

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subjects must meet all of the following criteria to be included in the study:

1. Witnessed, signed informed consent approved by Institutional Review Board/Independent Ethics Committee.

2. A signed Health Information Portability and Accountability Act (HIPAA) authorization form which permits the use and disclosure of subject's individually identifiable health information.

3. Male Subjects of any race 18 years of age and older.

4. Subjects with a clinical diagnosis of interdigital T. pedis T. pedis interdigital defined as lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot (the non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin).

5. Provisionally confirmed diagnosis at baseline by a positive potassium hydroxide (KOH) wet mount at the clinical site.

6. The sum of the clinical signs and symptoms scores of the target lesion is at least 4 using the Grading and signs and symptoms of T. pedis detailed in section 6.6.1, including a minimum score of at least 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).

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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

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.

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Related Conditions & MeSH terms

• Tinea
• Tinea Pedis

Intervention

Drug:
• J. Lividum
Investigational Product

Locations

Country	Name	City	State
Dominican Republic	Instituto Dermatologico y Cirugia de Piel	Santo Domingo

Sponsors (1)

Lead Sponsor	Collaborator
DermBiont, Inc.

Country where clinical trial is conducted

Dominican Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Tolerability	Tolerability will be evaluated through assessment local signs and symptoms. Scoring for Fissuring/Cracking, Erythema, Maceration, Scaling, Pruritus, Burning/Stinging: 0 = none (complete absence); = mild (slight); = moderate (definitely present); = severe (marked, intense)	Baseline (Day 1) to Day 28
Secondary	Efficacy 1: Presence and Persistence of J. lividum	Proportion of samples at each time point in which J. lividum can be detected.	28 Days
Secondary	Efficacy 2: Clinical Response	Changes in signs and symptoms of T. pedis Scoring Measure for Fissuring/Cracking, Erythema, Maceration, Scaling, Pruritus, Burning/Stinging: Scoring Measure: 0 = none (complete absence); = mild (slight); = moderate (definitely present); = severe (marked, intense)	28 Days