A Trial to Evaluate the Safety and Antimicrobial Efficacy of DBI-002 Probiotic in Adults With Tinea Versicolor

Study Overview
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Brief Summary
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A Randomized, Double-Blinded, Aqueous Gel-Controlled Dose Escalating Trial to Study the Safety and Antimicrobial Efficacy of DBI-002 Probiotic vs. Aqueous Gel and Vehicle Gel vs. Aqueous Gel in Adults with Tinea Versicolor (DBI-202).

Official Title
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A Randomized, Double-Blinded, Aqueous Gel-Controlled Dose Escalating Trial to Study the Safety and Antimicrobial Efficacy of DBI-002 Probiotic vs. Aqueous Gel and Vehicle Gel vs. Aqueous Gel in Adults With Tinea Versicolor

Conditions
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Tinea Versicolor

Intervention / Treatment
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* Biological: DBI-002 probiotic gel
* Biological: Aqueous gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to understand, agree to and sign the study Informed Consent Form (ICF). If the subject is unable to provide consent him/herself, the subject's legally acceptable representative may provide written consent. Male or Female Subjects of any race 18 - 65 years of age. Subjects with a clinical diagnosis of Tinea versicolor (TV is a common benign superficial cutaneous fungal infection usually characterized by hypopigmented or hyperpigmented macules and patches on the chest and back). A positive potassium hydroxide (KOH) examination consistent with Malassezia prior to the treatment period done at the clinical site. Agree to not use soap and water on the chest and back for at least 12 hours before the study visits for Baseline/Day 1, Day 5, and Day 14, and follow all study instructions for use of soap and water on the chest and back during participation in the study. Exclusion Criteria: Females who are pregnant, planning a pregnancy, or breastfeeding. Any dermatological conditions that could interfere with clinical evaluations or any disease state or physical condition which might expose the patient to an unacceptable risk by study participation. Any underlying disease(s) or other dermatological conditions that require the use of exclusionary topical or systemic therapy (see below). Known sensitivity to any of the components of the study medication. Use of a prescription or non-prescription topical treatment on the targeted TV anatomical locations within the previous 4 weeks, for example: anti-fungal, antibacterial or anti-microbial products, selenium and anti-inflammatories (e.g., corticosteroids). Use of a systemic anti-fungal or antibiotic treatment for TV within the previous 4 weeks, Use of medicated shampoos and/or soaps within the previous 4 weeks. 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 product(s) or any components in the investigational product(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure (IB). AIDS or AIDS related complex by medical history. Known or suspected use of immunosuppressive medications and/or has a known or suspected autoimmune disease. 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
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DBI-002 probiotic gel<br>Topical application of DBI-002 probiotic gel on skin affected with tinea versicolor | Biological: DBI-002 probiotic gel<br>* Topical application on skin affected with tinea versicolor<br>|
| Placebo Comparator: Aqueous gel<br>Topical application of aqueous gel on skin affected with tinea versicolor | Biological: Aqueous gel<br>* Topical application on skin affected with tinea versicolor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events | Safety | 14 days of participation | 
| Molecular diagnostic qPCR comparison of DBI-002 Drug Product and Malassezia (fungal cause of tinea versicolor) | Antimicrobial Efficacy | 14 days of participation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with decrease in signs and symptoms of tinea versicolor for the DBI-002 DP-treated lesion compared to the aqueous gel treated lesion | Clinical efficacy | 14 days of participation |