Tinea VersicolorPhase 2NCT04937920
A Trial to Evaluate the Safety and Antimicrobial Efficacy of DBI-002 Probiotic in Adults With Tinea Versicolor
A Phase 2 study testing DBI-002 probiotic gel and Aqueous gel in people with Tinea Versicolor, run by DermBiont, Inc. at 1 site in El Salvador.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tinea Versicolor
- What is being tested?
- DBI-002 probiotic gel and Aqueous gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteEl Salvador
- Study dates
- 16 Mar 2021to 4 Nov 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the detailed description
All subjects are required to have a clinical diagnosis of Tinea Versicolor on their chest and back. Each subject will serve as their own control, with aqueous gel applied to the chest or back, and the non-aqueous gel (DBI-002 or vehicle) applied to the opposite side. Treatment kits will be assigned sequentially to subjects. The subject and the investigator will be blinded to the pre-defined randomization assignments.
In this Phase IIA proof-of-mechanism study, cohorts 1, 2, and 3 were designed to be similar to a dose-escalating study. These cohorts will be enrolled sequentially, with a safety pause in between cohorts to evaluate events and/or local tolerability to topical application of the investigational product (DBI-002) or aqueous gel. Within each cohort, the first two subjects enrolled will have a single application of DBI-002 and aqueous gel, with a pause to assess adverse events and local tolerability. In the absence of safety concerns, the remaining subjects in that cohort will be enrolled to receive five consecutive daily applications of DBI-002 and aqueous gel. Cohort 1 will be low dose. Cohort 2 will be medium dose. Cohort 3 will be high dose. In the absence of safety concerns, the Investigator will proceed to enroll the next cohort, or extend (EXT) the enrollment of a cohort upon receiving Ethics Committee approval. Single-dose subjects remain in their original single-dose cohort assignment and do not dose-escalate, nor participate in the multiple-dose portion of that cohort, nor Cohort 4.
The fourth cohort, Cohort 4, was designed to compare vehicle with aqueous gel. All subjects in this cohort will be required to receive five consecutive daily applications of vehicle and aqueous gel. The Investigator may enroll cohort 4 in parallel with the above cohorts.
- Conditions
- Tinea Versicolor
- Being tested
- DBI-002 probiotic gel, Aqueous gel
- Medical subject headings
- Tinea Versicolor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBI-002 probiotic gelBiological
Topical application on skin affected with tinea versicolor
Aqueous gelBiological
Topical application on skin affected with tinea versicolor
| Study group | Role | What they receive |
|---|---|---|
| DBI-002 probiotic gel | Active comparator | Topical application of DBI-002 probiotic gel on skin affected with tinea versicolor Receives: Biological: DBI-002 probiotic gel |
| Aqueous gel | Placebo comparator | Topical application of aqueous gel on skin affected with tinea versicolor Receives: Biological: Aqueous gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The secondary analysis will summarize the number of subjects with more improvement in individual signs and symptoms of TV between DBI-002 Drug Product (Active) and aqueous gel (Control) at Day 5 or Day 14 versus Baseline
Measured: 14 days of participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start16 Mar 2021
- Primary completion20 Sep 2021
- Study completion4 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tinea VersicolorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- DermBiont, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Zepeda, MD, Principal investigator, Zepeda Dermatologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937920
- Sponsor's protocol ID
- DBI-202
- Status last verified
- Apr 2025
- First submitted
- 1 Jun 2021
- Last updated
- 3 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04937920
- Acronym / sponsor ID
- DBI-202
- Conditions
- Tinea Versicolor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- DermBiont, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 4 Nov 2021 (actual)
- First posted
- 24 Jun 2021 (actual)
- Results
- Posted 3 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
All subjects are required to have a clinical diagnosis of Tinea Versicolor on their chest and back. Each subject will serve as their own control, with aqueous gel applied to the chest or back, and the non-aqueous gel (DBI-002 or vehicle) applied to the opposite side. Treatment kits will be assigned sequentially to subjects. The subject and the investigator will be blinded to the pre-defined randomization assignments.
In this Phase IIA proof-of-mechanism study, cohorts 1, 2, and 3 were designed to be similar to a dose-escalating study. These cohorts will be enrolled sequentially, with a safety pause in between cohorts to evaluate events and/or local tolerability to topical application of the investigational product (DBI-002) or aqueous gel. Within each cohort, the first two subjects enrolled will have a single application of DBI-002 and aqueous gel, with a pause to assess adverse events and local tolerability. In the absence of safety concerns, the remaining subjects in that cohort will be enrolled to receive five consecutive daily applications of DBI-002 and aqueous gel. Cohort 1 will be low dose. Cohort 2 will be medium dose. Cohort 3 will be high dose. In the absence of safety concerns, the Investigator will proceed to enroll the next cohort, or extend (EXT) the enrollment of a cohort upon receiving Ethics Committee approval. Single-dose subjects remain in their original single-dose cohort assignment and do not dose-escalate, nor participate in the multiple-dose portion of that cohort, nor Cohort 4.
The fourth cohort, Cohort 4, was designed to compare vehicle with aqueous gel. All subjects in this cohort will be required to receive five consecutive daily applications of vehicle and aqueous gel. The Investigator may enroll cohort 4 in parallel with the above cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBI-002 probiotic gel | Active comparator | Biological: DBI-002 probiotic gelTopical application of DBI-002 probiotic gel on skin affected with tinea versicolor |
| Aqueous gel | Placebo comparator | Biological: Aqueous gelTopical application of aqueous gel on skin affected with tinea versicolor |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBI-002 probiotic gelTopical application on skin affected with tinea versicolor | Biological | DBI-002 probiotic gel |
| Aqueous gelTopical application on skin affected with tinea versicolor | Biological | Aqueous gel |
Primary outcome
Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor)
Time frame: 14 days of participation
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.
1 secondary outcome
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
Time frame: 14 days of participation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Zepeda, MD principal investigator
Zepeda Dermatologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DBI-002 probiotic gel and Aqueous gel in people with Tinea Versicolor, run by DermBiont, Inc. at 1 site in El Salvador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in El Salvador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) (time frame: 14 days of participation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.