Trial Outcomes & Findings for A Trial to Evaluate the Safety and Antimicrobial Efficacy of DBI-002 Probiotic in Adults With Tinea Versicolor (NCT NCT04937920)

Last Updated: 2025-07-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

14 days of participation

Results posted on

2025-07-03

Participant Flow

All subjects are required to have Tinea Versicolor on their chest and back, with no pre-assignment, as each subject functions as their own control. Each subject had test article (aqueous gel and active) applied, randomized, within treatment sites to 100cm2. The dose-escalating DBI-002 cohorts (1, 2, and 3) were enrolled in sequence, with a safety pause between cohorts to assess adverse events and local reactions to topical application. 34 total subjects were enrolled and received treatment.

Unit of analysis: Treatment sites

Participant milestones

Participant milestones
Measure	Cohort 1 Low dose 10\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose (first 2 subjects) OR Once-daily application for 5 consecutive days (last 4 subjects) Safety pauses between single and multi-dose subjects, and prior to enrolling next cohort. No subject is dose escalated. Subjects are enrolled in only one cohort.	Cohort 2 Medium dose 10\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose (first 2 subjects) OR Once-daily application for 5 consecutive days (last 4 subjects) Safety pauses between single and multi-dose subjects, and prior to enrolling next cohort. No subject is dose escalated. Subjects are enrolled in only one cohort.	Cohort 3 High dose 10\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose (first 2 subjects) OR Once-daily application for 5 consecutive days (last 4 subjects) Safety pauses between single and multi-dose subjects, and prior to enrolling next cohort. No subject is dose escalated. Subjects are enrolled in only one cohort.	Cohort 1EXT Low dose 10\^6 CFUs/ml of DBI- 002 probiotic vs. aqueous gel Once-daily application for 5 consecutive days (4 subjects) Safety pause prior to enrolling next cohort. No subject is dose escalated. Subjects are enrolled in only one cohort.	Cohort 2EXT Medium dose 10\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel Once-daily application for 5 consecutive days (4 subjects) Safety pause prior to enrolling next cohort. No subject is dose escalated. Subjects are enrolled in only one cohort.	Cohort 3EXT High dose 10\^10 CFUs/ml of DBI- 002 probiotic vs. aqueous gel Once-daily application for 5 consecutive days (4 subjects) Safety pause prior to enrolling next cohort. No subject is dose escalated. Subjects are enrolled in only one cohort	Cohort 4 Vehicle gel vs. aqueous (CMC) gel Once-daily application for 5 consecutive days
Overall Study STARTED	6 12	6 12	6 12	4 8	4 8	4 8	4 8
Overall Study Aqueous Gel (Back or Chest)	6 6	6 6	6 6	4 4	4 4	4 4	4 4
Overall Study DBI-002 Probiotic (Back or Chest)	6 6	6 6	6 6	4 4	4 4	4 4	0 0
Overall Study Vehicle Gel (Back or Chest)	0 0	0 0	0 0	0 0	0 0	0 0	4 4
Overall Study COMPLETED	6 12	6 12	6 12	4 8	4 8	4 8	4 8
Overall Study NOT COMPLETED	0 0	0 0	0 0	0 0	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=6 Participants Low dose 10\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days	Cohort 2 n=6 Participants Medium dose 10\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days	Cohort 3 n=6 Participants High dose 10\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days	Cohort 1EXT n=4 Participants Low dose 10\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days	Cohort 2EXT n=4 Participants Medium dose 10\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days	Cohort 3EXT n=4 Participants High dose 10\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days	Cohort 4 n=4 Participants Vehicle gel vs. aqueous (CMC) gel Once-daily application for 5 consecutive days	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=8 Participants	4 Participants n=8 Participants	34 Participants n=24 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Age, Continuous	33.0 Years STANDARD_DEVIATION 10.6 • n=5 Participants	24.5 Years STANDARD_DEVIATION 1.52 • n=7 Participants	29.0 Years STANDARD_DEVIATION 8.22 • n=5 Participants	29.0 Years STANDARD_DEVIATION 8.29 • n=4 Participants	47.3 Years STANDARD_DEVIATION 13.6 • n=21 Participants	31.3 Years STANDARD_DEVIATION 13.1 • n=8 Participants	34.8 Years STANDARD_DEVIATION 13.1 • n=8 Participants	32.0 Years STANDARD_DEVIATION 11.2 • n=24 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	12 Participants n=24 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	4 Participants n=8 Participants	22 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=8 Participants	4 Participants n=8 Participants	34 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Region of Enrollment El Salvador	6 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	4 participants n=4 Participants	4 participants n=21 Participants	4 participants n=8 Participants	4 participants n=8 Participants	34 participants n=24 Participants
Clinical diagnosis of Tinea Versicolor on the chest and back	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=8 Participants	4 Participants n=8 Participants	34 Participants n=24 Participants

PRIMARY outcome

Timeframe: 14 days of participation

Population: The primary analysis will compare the differences at Day 5 between DBI-002 Drug Product (DP), vehicle gel, and/or aqueous gel in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.

Outcome measures

Outcome measures
Measure	Cohort 1 n=6 Participants Low dose 10\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days	Cohort 2 n=6 Participants Medium dose 10\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days	Cohort 3 n=6 Participants High dose 10\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days	Cohort 1EXT n=4 Participants Low dose 10\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days	Cohort 2EXT n=4 Participants Medium dose 10\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive day	Cohort 3EXT n=4 Participants High dose 10\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days
Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) Day 5 qPCR DBI-002 Drug Product: # Subjects where Active Improves More than Aqueous Gel (Control)	2 Participants	4 Participants	5 Participants	1 Participants	1 Participants	4 Participants
Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) Day 14 qPCR DBI-002 Drug Product: # Subjects where Active Improves More than Aqueous Gel (Control)	0 Participants	1 Participants	4 Participants	0 Participants	0 Participants	2 Participants
Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) Day 5 qPCR Malassezia(fungal cause of TV):# Subjects where Active Improves More than Aqueous Gel	3 Participants	5 Participants	5 Participants	4 Participants	4 Participants	2 Participants
Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) Day 14 qPCR Malassezia(fungal cause of TV):# Subjects where Active Improves More than Aqueous Gel	3 Participants	3 Participants	4 Participants	3 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 14 days of participation

Population: The proportion of subjects with a greater decrease in the scoring of individual signs and symptoms of TV for the DBI-002 Drug Product-treated lesion than the vehicle-treated or aqueous gel-treated lesion is be summarized descriptively for Days 5 and 14.

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

Outcome measures

Outcome measures
Measure	Cohort 1 n=6 Participants Low dose 10\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days	Cohort 2 n=6 Participants Medium dose 10\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days	Cohort 3 n=6 Participants High dose 10\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days	Cohort 1EXT n=4 Participants Low dose 10\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days	Cohort 2EXT n=4 Participants Medium dose 10\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive day	Cohort 3EXT n=4 Participants High dose 10\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days
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 Day 5 proportion of subjects with a greater decrease in the scoring of individual signs and symptoms	2 Participants	2 Participants	2 Participants	2 Participants	1 Participants	2 Participants
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 Day 14 proportion of subjects with a greater decrease in the scoring of individual signs and symptom	3 Participants	3 Participants	3 Participants	2 Participants	1 Participants	2 Participants

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cohort 1 Probiotic Gel n=6 participants at risk Low dose 10\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days	Cohort 1 Aqueous Gel n=6 participants at risk Low dose 10\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days	Cohort 2 Probiotic Gel n=6 participants at risk Medium dose 10\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days	Cohort 2 Aqueous Gel n=6 participants at risk Medium dose 10\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days	Cohort 3 Aqueous Gel n=6 participants at risk High dose 10\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days	Cohort 3 Probiotic Gel n=6 participants at risk High dose 10\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days	Cohort 1EXT Aqueous Gel n=4 participants at risk Low dose 10\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days	Cohort 1EXT Probiotic Gel n=4 participants at risk Low dose 10\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days	Cohort 2EXT Aqueous Gel n=4 participants at risk Medium dose 10\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days	Cohort 2EXT Probiotic Gel n=4 participants at risk Medium dose 10\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days	Cohort 3EXT Aqueous Gel n=4 participants at risk High dose 10\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days	Cohort 3EXT Probiotic Gel n=4 participants at risk High dose 10\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days	Cohort 4 Aqueous n=4 participants at risk Vehicle gel vs. aqueous (CMC) gel Once-daily application for 5 consecutive days	Cohort 4 Probiotic n=4 participants at risk Vehicle gel vs. aqueous (CMC) gel Once-daily application for 5 consecutive days
General disorders Headache	0.00% 0/6 • Day 14 (Visit 6) from the baseline Day 1 (Visit 1) AE is any untoward medical occurrence in a subject administered a pharmaceutical product, that doesn't necessarily have a causal relationship with the treatment.It can be any unfavorable \& unintended sign(e.g., an abnormal laboratory finding), symptom/ disease temporally associated with use of the study drug, whether or not it's considered to be drug related.This includes any newly occurring event/previous condition that has increased in severity/frequency since the administration of study drug.	0.00% 0/6 • Day 14 (Visit 6) from the baseline Day 1 (Visit 1) AE is any untoward medical occurrence in a subject administered a pharmaceutical product, that doesn't necessarily have a causal relationship with the treatment.It can be any unfavorable \& unintended sign(e.g., an abnormal laboratory finding), symptom/ disease temporally associated with use of the study drug, whether or not it's considered to be drug related.This includes any newly occurring event/previous condition that has increased in severity/frequency since the administration of study drug.	0.00% 0/6 • Day 14 (Visit 6) from the baseline Day 1 (Visit 1) AE is any untoward medical occurrence in a subject administered a pharmaceutical product, that doesn't necessarily have a causal relationship with the treatment.It can be any unfavorable \& unintended sign(e.g., an abnormal laboratory finding), symptom/ disease temporally associated with use of the study drug, whether or not it's considered to be drug related.This includes any newly occurring event/previous condition that has increased in severity/frequency since the administration of study drug.	0.00% 0/6 • Day 14 (Visit 6) from the baseline Day 1 (Visit 1) AE is any untoward medical occurrence in a subject administered a pharmaceutical product, that doesn't necessarily have a causal relationship with the treatment.It can be any unfavorable \& unintended sign(e.g., an abnormal laboratory finding), symptom/ disease temporally associated with use of the study drug, whether or not it's considered to be drug related.This includes any newly occurring event/previous condition that has increased in severity/frequency since the administration of study drug.	0.00% 0/6 • Day 14 (Visit 6) from the baseline Day 1 (Visit 1) AE is any untoward medical occurrence in a subject administered a pharmaceutical product, that doesn't necessarily have a causal relationship with the treatment.It can be any unfavorable \& unintended sign(e.g., an abnormal laboratory finding), symptom/ disease temporally associated with use of the study drug, whether or not it's considered to be drug related.This includes any newly occurring event/previous condition that has increased in severity/frequency since the administration of study drug.	0.00% 0/6 • Day 14 (Visit 6) from the baseline Day 1 (Visit 1) AE is any untoward medical occurrence in a subject administered a pharmaceutical product, that doesn't necessarily have a causal relationship with the treatment.It can be any unfavorable \& unintended sign(e.g., an abnormal laboratory finding), symptom/ disease temporally associated with use of the study drug, whether or not it's considered to be drug related.This includes any newly occurring event/previous condition that has increased in severity/frequency since the administration of study drug.	0.00% 0/4 • Day 14 (Visit 6) from the baseline Day 1 (Visit 1) AE is any untoward medical occurrence in a subject administered a pharmaceutical product, that doesn't necessarily have a causal relationship with the treatment.It can be any unfavorable \& unintended sign(e.g., an abnormal laboratory finding), symptom/ disease temporally associated with use of the study drug, whether or not it's considered to be drug related.This includes any newly occurring event/previous condition that has increased in severity/frequency since the administration of study drug.	25.0% 1/4 • Day 14 (Visit 6) from the baseline Day 1 (Visit 1) AE is any untoward medical occurrence in a subject administered a pharmaceutical product, that doesn't necessarily have a causal relationship with the treatment.It can be any unfavorable \& unintended sign(e.g., an abnormal laboratory finding), symptom/ disease temporally associated with use of the study drug, whether or not it's considered to be drug related.This includes any newly occurring event/previous condition that has increased in severity/frequency since the administration of study drug.	0.00% 0/4 • Day 14 (Visit 6) from the baseline Day 1 (Visit 1) AE is any untoward medical occurrence in a subject administered a pharmaceutical product, that doesn't necessarily have a causal relationship with the treatment.It can be any unfavorable \& unintended sign(e.g., an abnormal laboratory finding), symptom/ disease temporally associated with use of the study drug, whether or not it's considered to be drug related.This includes any newly occurring event/previous condition that has increased in severity/frequency since the administration of study drug.	0.00% 0/4 • Day 14 (Visit 6) from the baseline Day 1 (Visit 1) AE is any untoward medical occurrence in a subject administered a pharmaceutical product, that doesn't necessarily have a causal relationship with the treatment.It can be any unfavorable \& unintended sign(e.g., an abnormal laboratory finding), symptom/ disease temporally associated with use of the study drug, whether or not it's considered to be drug related.This includes any newly occurring event/previous condition that has increased in severity/frequency since the administration of study drug.	0.00% 0/4 • Day 14 (Visit 6) from the baseline Day 1 (Visit 1) AE is any untoward medical occurrence in a subject administered a pharmaceutical product, that doesn't necessarily have a causal relationship with the treatment.It can be any unfavorable \& unintended sign(e.g., an abnormal laboratory finding), symptom/ disease temporally associated with use of the study drug, whether or not it's considered to be drug related.This includes any newly occurring event/previous condition that has increased in severity/frequency since the administration of study drug.	0.00% 0/4 • Day 14 (Visit 6) from the baseline Day 1 (Visit 1) AE is any untoward medical occurrence in a subject administered a pharmaceutical product, that doesn't necessarily have a causal relationship with the treatment.It can be any unfavorable \& unintended sign(e.g., an abnormal laboratory finding), symptom/ disease temporally associated with use of the study drug, whether or not it's considered to be drug related.This includes any newly occurring event/previous condition that has increased in severity/frequency since the administration of study drug.	0.00% 0/4 • Day 14 (Visit 6) from the baseline Day 1 (Visit 1) AE is any untoward medical occurrence in a subject administered a pharmaceutical product, that doesn't necessarily have a causal relationship with the treatment.It can be any unfavorable \& unintended sign(e.g., an abnormal laboratory finding), symptom/ disease temporally associated with use of the study drug, whether or not it's considered to be drug related.This includes any newly occurring event/previous condition that has increased in severity/frequency since the administration of study drug.	0.00% 0/4 • Day 14 (Visit 6) from the baseline Day 1 (Visit 1) AE is any untoward medical occurrence in a subject administered a pharmaceutical product, that doesn't necessarily have a causal relationship with the treatment.It can be any unfavorable \& unintended sign(e.g., an abnormal laboratory finding), symptom/ disease temporally associated with use of the study drug, whether or not it's considered to be drug related.This includes any newly occurring event/previous condition that has increased in severity/frequency since the administration of study drug.

Additional Information

Emma Taylor, MD (Chief Medical Officer)

DermBiont, Inc

Phone: 510-607-8155

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER