A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Tinea Pedis

Exclusion Criteria

• •1. Women who are pregnant, planning a pregnancy, breastfeeding or have a positive pregnancy test at screening.
• •2. Any dermatological conditions that could interfere with clinical evaluations
• •3. The clinical diagnosis of moccasin T. pedis.
• •4. Subjects with gram negative interdigital tinea pedis based on a clinical diagnosis: Gram-negative athlete's foot - the interspace is foul smelling, whitish, painful, strongly macerated, and hyperkeratotic with erosions, exudation, and intense inflammation and often disabling.
• •5. Any underlying disease(s) or other dermatological condition that requires the use of interfering topical or systemic therapy.
• •6. Subjects with concurrent use of any of the following topical preparations who have not completed the specified washout period(s) for the following topical medications applied to the foot at the time of the Screening visit:
• •1. Washout of 1 week prior to the screening visit for topical astringents and abrasives (e.g., Burrow's solution), Vicks VapoRub, tea tree oil)
• •2. Washout of 2 weeks prior to the screening visit for topical antibiotics and antifungal on the feet (e.g., Neomycin, Miconazole, Clotrimazole, Terbinafine)
• •3. Washout of 4 weeks prior to the screening visit for the topical Anti-inflammatories, corticosteroids, topical immunomodulators on the feet (e.g., Pimecrolimus, Tacrolimus)
• •7. Subjects with concurrent use of any of the following systemic medications who have not completed the specified washout period(s) for the following systemic medications at the time of the Screening visit:
• •1. Washout of 4 weeks prior to the screening visit for the systemic corticosteroids (including intramuscular injections) (e.g., Triamcinolone acetonide)
• •2. Washout of 4 weeks prior to the screening visit for the systemic antibiotics (e.g., Tetracycline, Cephalosporins, etc.) and/or Antifungal agents (e.g., Fluconazole, Itraconazole, Terbinafine, etc.)
• •3. Washout of 4 weeks prior to the screening visit for the systemic immunomodulators (e.g., Cyclophosphamide, Azathioprine, Biologicals-Monoclonal Antibodies)
• •8. Treatment of any type of cancer within the last 6 months except for superficial skin cancers such as basal cell carcinoma and squamous cell carcinoma.
• •9. History of any significant internal disease which contraindicates use of a live microbiome (e.g., leukemia, liver failure, cardiovascular disease).
• •10. Subjects who are known to be allergic to any of the Test article(s) or any components in the test article(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure.
• •11. AIDS or AIDS related complex by medical history.
• •12. History of current street drug or alcohol abuse, or street drug or alcohol abuse within the past year.
• •13. Known or suspected immune suppressive medications or diseases.
• •14. Subjects with poorly controlled diabetes mellitus Type I or II requiring medical intervention/treatment.
• •15. Peripheral vascular disease based on medical history.
• •16. Any subject not able to meet the study attendance requirements.
• •17. 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.
• •18. Use of any orthopedic appliance (e.g., cast, soft cast, splint) on either foot or ankle, or surgery of either foot or ankle within 90 days of the Screening visit.