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

NCT04937920 | Completed Phase 2 Results

• 1 other identifier: DBI-202
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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).

Conditions

Tinea Versicolor

Outcome Measures

Primary Outcomes (1)

• Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor)

  The primary analysis will summarize the number of subjects with more qPCR DBI-002 drug product and more improvement in qPCR Malassezia (fungal cause of tinea versicolor) between DBI-002 Drug Product (Active) and aqueous gel (Control) at Day 5 or Day 14 versus Baseline.

  14 days of participation

Secondary Outcomes (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

Study Arms (2)

DBI-002 probiotic gel

ACTIVE COMPARATOR

Topical application of DBI-002 probiotic gel on skin affected with tinea versicolor

Biological: DBI-002 probiotic gel

Aqueous gel

PLACEBO COMPARATOR

Topical application of aqueous gel on skin affected with tinea versicolor

Biological: Aqueous gel

Interventions

DBI-002 probiotic gel BIOLOGICAL

Topical application on skin affected with tinea versicolor

DBI-002 probiotic gel

Aqueous gel BIOLOGICAL

Topical application on skin affected with tinea versicolor

Aqueous gel

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• DermBiont, Inc.: lead

Study Sites (1)

Zepeda Dermatologia

Santa Tecla, La Libertad Department, El Salvador

Location

MeSH Terms

Conditions

Tinea Versicolor

Interventions

BANG polymer gel

Condition Hierarchy (Ancestors)

Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Emma Taylor, MD (Chief Medical Officer)
• Organization: DermBiont, Inc

emma@dermbiont.com

510-607-8155

Study Officials

• David Zepeda, MD

  Zepeda Dermatologia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 24, 2021
• Study Start: March 16, 2021
• Primary Completion: September 20, 2021
• Study Completion: November 4, 2021
• Last Updated: July 3, 2025
• Results First Posted: July 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EL (1)