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

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.