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

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.

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

Eligibility Criteria:
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).

   -

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.

    -