A Trial of Safety/Efficacy of Test Article in Patients With Interdigital T. Pedis

Study Overview
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Brief Summary
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Placebo Controlled Trial of the Safety and Efficacy of DBI-001 in Patients with Interdigital Tinea pedis (T. pedis)

Detailed Description
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Double-Blind, Randomized, Placebo Controlled Trial of the Safety and Efficacy of DBI-001 Gel in Patients with Interdigital Tinea pedis (T. pedis). The primary objective is to observe the antimicrobial effect of a daily application of DBI-001Gel for 4 weeks in patients with interdigital T. pedis based on the change from culture positive for a dermatophyte to culture negative as determined by routine mycology culture.

Official Title
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Clinical Trial Protocol DBI-204 Double-Blind, Randomized, Placebo Controlled Trial of the Safety and Efficacy of DBI-001 Gel in Patients With Interdigital Tinea Pedis

Conditions
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Interdigital Tinea Pedis

Intervention / Treatment
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* Drug: Cohort 1 J. Lividum
* Other: Placebo Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must meet all of the following criteria to be included in the study: A signed approved informed consent form by Institutional Review Board/Independent Ethics Committee. A signed Health Information Portability and Accountability Act (HIPAA) authorization form which permits the use and disclosure of subject's individually identifiable health information. Male or Female Subjects of any race 18 years of age and older. 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. 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). Provisionally confirmed diagnosis at screening by a positive potassium hydroxide (KOH) wet mount at the clinical site. A positive dermatophyte culture from the sample obtained at the screening visit. 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). 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: Females who are pregnant, planning a pregnancy, breastfeeding or have a positive pregnancy test at the site. Any dermatological conditions that could interfere with clinical evaluations. The clinical diagnosis of moccasin T. pedis. Any underlying disease(s) or some other dermatological condition that requires the use of interfering topical or systemic therapy. 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. Subjects that have not undergone the washout periods for systemic medications or who require the use of specific systemic medications. Treatment of any type of cancer within the last 6 months. History of any significant internal disease (which contraindicates use of live microbiome e.g. leukemia, liver failure, cardiovascular disease). 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. AIDS or AIDS related complex by medical history. Known or suspected immune suppressive medications or diseases. Diabetes mellitus Type I or II by medical history. Peripheral vascular disease based on medical history. Any subject not able to meet the study attendance requirements. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Double-Blind, Randomized, Placebo Controlled trial of the Safety and Efficacy of DBI-001 Gel in patients with interdigital T. pedis. Test articles will be applied by subjects once daily at bedtime for a period of four (4) weeks.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Gel<br>Placebo gel daily application for 4 weeks | Other: Placebo Gel<br>* Subject to apply Placebo Gel daily on each foot covering all web spaces, the plantar and lateral aspects, toes and toenails.<br>|
| Active Comparator: Cohort 1<br>DBI-001 Gel daily application for 4 weeks | Drug: Cohort 1 J. Lividum<br>* Subject to apply DBI-001 Gel on each foot covering all web spaces, the plantar and lateral aspects, toes and toenails<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| From Culture Positive to Culture Negative | Antimicrobial effect. Effect will be measured by change from culture positive for dermatophyte to culture negative as determined by routine mycology culture. | Baseline (Day 1) to Day 28 |