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

• Sponsor: DermBiont, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04937920
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.7
• Patients Per Site Per Month: 4.4

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Tinea Versicolor	Biological: DBI-002 probiotic gel; Biological: Aqueous gel	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Mar 16, 2021
• Actual Primary Completion Date: Sep 20, 2021
• Actual Study Completion Date: Nov 4, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: DBI-002 probiotic gel Topical application of DBI-002 probiotic gel on skin affected with tinea versicolor	Biological: DBI-002 probiotic gel; Topical application on skin affected with tinea versicolor
Placebo Comparator: Aqueous gel Topical application of aqueous gel on skin affected with tinea versicolor	Biological: Aqueous gel; Topical application on skin affected with tinea versicolor

Outcome Measures

Primary Outcome Measures

1. Number of participants with treatment-related adverse events [14 days of participation]

   Safety

2. Molecular diagnostic qPCR comparison of DBI-002 Drug Product and Malassezia (fungal cause of tinea versicolor) [14 days of participation]

   Antimicrobial Efficacy

Secondary Outcome Measures

1. 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 [14 days of participation]

   Clinical efficacy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 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.

2. Male or Female Subjects of any race 18 - 65 years of age.

3. 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).

4. A positive potassium hydroxide (KOH) examination consistent with Malassezia prior to the treatment period done at the clinical site.

5. 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:

1. Females who are pregnant, planning a pregnancy, or breastfeeding.

2. 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.

3. Any underlying disease(s) or other dermatological conditions that require the use of exclusionary topical or systemic therapy (see below).

4. Known sensitivity to any of the components of the study medication.

5. 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).

6. 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.

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 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).

10. AIDS or AIDS related complex by medical history.

11. Known or suspected use of immunosuppressive medications and/or has a known or suspected autoimmune disease.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zepeda Dermatologia	Santa Tecla	La Libertad	El Salvador

Sponsors and Collaborators

• DermBiont, Inc.

Investigators

• Principal Investigator: David Zepeda, MD, Zepeda Dermatologia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: DermBiont, Inc.
• ClinicalTrials.gov Identifier: NCT04937920
• Other Study ID Numbers: DBI-202
• First Posted: Jun 24, 2021
• Last Update Posted: Nov 29, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tinea; Tinea Versicolor

Study Results

No Results Posted as of Nov 29, 2021