| Eligibility |
Inclusion Criteria:
- Subjects must meet all of the following criteria to be included in the study:
1. A signed approved informed consent form 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 or Female Subjects of any race 18 years of age and older.
4. Women patients of child-bearing potential must: a. Have negative urine pregnancy
tests prior to study treatment to rule out pregnancy, and b. Use at least one
method of birth control that results in a low failure rate (i.e. less than 1% per
year) when used consistently and correctly such as implants, injectables,
combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence
or vasectomized partner for the duration of study participation.
5. 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).
6. Provisionally confirmed diagnosis at screening by a positive potassium hydroxide
(KOH) wet mount at the clinical site.
7. A positive dermatophyte culture from the sample obtained at the screening visit.
8. The sum of the clinical signs and symptoms scores of at least one web space
(Target web space) is at least 4 using the Grading of Signs and Symptoms of T.
pedis 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).
9. Target web space should have adequate amount of leading-edge scale to provide
enough scale for KOH, fungal culture and molecular diagnostics.
Exclusion Criteria:
Subjects with the following will be excluded from this study:
1. Females who are pregnant, planning a pregnancy, breastfeeding or have a positive
pregnancy test at the site.
2. Any dermatological conditions that could interfere with clinical evaluations.
3. The clinical diagnosis of moccasin T. pedis.
4. Any underlying disease(s) or some other dermatological condition that requires
the use of interfering topical or systemic therapy.
5. Subjects that have not undergone the specified washout period(s) or subjects who
require the concurrent use of specific topical medications applied to the foot.
6. Subjects that have not undergone the washout periods for systemic medications or
who require the use of specific systemic medications.
7. Treatment of any type of cancer within the last 6 months.
8. History of any significant internal disease (which contraindicates use of live
microbiome e.g. leukemia, liver failure, cardiovascular disease).
9. 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.
10. AIDS or AIDS related complex by medical history.
11. Known or suspected immune suppressive medications or diseases.
12. Diabetes mellitus Type I or II by medical history.
13. Peripheral vascular disease based on medical history.
14. Any subject not able to meet the study attendance requirements.
15. 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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