Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT04937920
Status:
COMPLETED
Last Update Posted:
2025-07-03
First Post:
2021-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Trial to Evaluate the Safety and Antimicrobial Efficacy of DBI-002 Probiotic in Adults With Tinea Versicolor
Sponsor:
DermBiont, Inc.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: