A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Onychomycosis
Primary Purpose
Onychomycosis
Status
Suspended
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DBI-001
DBI-002
Aqueous Gel
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis
Eligibility Criteria
Inclusion Criteria:
- 18 to 50 years of age, inclusive, at Screening
- Willing to abstain from all cosmetic activities involving the toenails during the entire course of the study
- Distal subungual onychomycosis defined as a great toenail with onycholysis and thickening of the nail bed with keratinous material
- Willing to have his/her treatment-targeted great toenail(s) clipped to remove onycholytic nail plate at each visit
- At least one treatment-targeted great toenail must have at least 6 mm of clear nail from the proximal nail fold to the proximal limit of disease and, after trimming to within 1mm distal nail groove, have at least 3mm of involved nail from distal nail groove to proximal limit of disease
- Confirmed presence of microorganisms of interest by KOH and qPCR at Screening
- The affected treatment-targeted great toenail(s) is capable of re-growth as documented by subject self-reported history of clipping nails at least monthly
Exclusion Criteria:
- Positive urine pregnancy test, pregnant, lactating, or female of childbearing potential who does not agree to use an active method of birth control for the duration of the study
- Any dermatological conditions that could interfere with clinical evaluations
- Great toenails with only superficial white onychomycosis, any evidence of subungual mycetoma as evidenced by yellow or white spikes, or any evidence of proximal onychomycosis
- Any underlying disease(s) or other dermatological condition(s) that requires the use of interfering topical or systemic therapy, with the exception of certain protocol-specified that require a defined washout period for eligibility
- Treatment of any type of cancer within the last 6 months, with the exception of superficial skin cancers such as basal cell carcinoma and squamous cell carcinoma
- History of any significant internal disease which contraindicates the use of live microbiome
- History of failing oral or prescription topical treatment for onychomycosis
- A history of current episode of onychomycosis present for more than 3 years
- Nail or anatomic abnormalities of the target great toenail(s)
- AIDS or AIDS-related complex by medical history
- History of current street drug or alcohol abuse, or street drug or alcohol abuse within the past year
- Subjects known or suspected to be taking immune suppressive medications or subjects who are immunosuppressed
- Subjects with poorly controlled diabetes mellitus requiring medical intervention/treatment
- Subjects with peripheral vascular disease based on medical history
- Subjects who have participated in any other trial of an investigational drug or device within 60 days prior to enrollment or participation in a research study concurrent with this study
Sites / Locations
- T. Joseph Raoof MD, Inc./Encino Research Center
- Minnesota Clinical Study Center
- Oregon Dermatology and Research Center
- DermResearch
- North Sound Dermatology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
DBI-001 Gel
DBI-002 Gel
Aqueous Gel
Arm Description
Topical application of DBI-001 gel on foot/feet affected with onychomycosis.
Topical application of DBI-002 gel on foot/feet affected with onychomycosis.
Topical application of aqueous gel on foot/feet affected with onychomycosis.
Outcomes
Primary Outcome Measures
Change in percentage of involved great toenail(s)
Absolute change from Baseline in percent of involved treatment-targeted great toenail(s) at Week 24.
Changes in signs and symptoms of Onychomycosis
Change from baseline in individual signs and symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48 of sites treated with DBI-001 Gel or DBI-002 Gel. The minimum value is 0 and the maximum value is 4.
Secondary Outcome Measures
Change in percentage of involved great toenail(s)
Absolute change from Baseline in percent of involved treatment-targeted great toenail(s) at Week 48.
Population with completely clear nail growth
Proportion of subjects with completely clear nail growth of the treatment-targeted great toenail(s) at Weeks 24 and 48 based on measurements from digital images.
Change in Investigator's Static Global Assessment (ISGA)
Change from Baseline in Investigator's Static Global Assessment (ISGA) for the treatment-targeted great toenail(s) at Weeks 24 and 48. The minimum value of ISGA is 0 and the maximum value is 4.
Length of new clear nail growth
Length in mm of new clear nail growth based on measurements from digital images at Weeks 24 and 48 of treatment-targeted great toenail(s).
Molecular diagnostic quantitative polymerase chain reaction (qPCR) and whole genome sequencing (WGS) comparison of DBI-001 Gel, DBI-002 Gel and Aqueous Gel on the impact of T. rubrum levels
Antimicrobial efficacy and microbiome community analysis
Change in colony forming units after using DBI-001 Gel or DBI-002 Gel or Aqueous Gel at Weeks 24 and 48
Antimicrobial efficacy
Evaluate the presence of DBI-001, DBI-002 based on qPCR and WGS and Weeks 24 and 48
Antimicrobial efficacy and microbiome community analysis
Evaluate the effect of DBI-001 Gel and DBI-002 Gel on the change in relative abundance and diversity of the cutaneous microbiome of the great toenail(s) from Screening to Weeks 24 and 48 as measured by WGS
Antimicrobial efficacy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05491603
Brief Title
A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Onychomycosis
Official Title
An Observer-Blinded, Randomized, Aqueous Gel-Controlled Trial of the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Onychomycosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Suspended
Why Stopped
Suspended: Study halted prematurely but potentially will resume. Sponsor suspension, and not due to safety or site-related matters.
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DermBiont, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a randomized, observer-blinded, Aqueous Gel-controlled trial examining the safety and efficacy of daily application of DBI-001 Gel vs. DBI-002 Gel vs. Aqueous Gel for 24 consecutive weeks in subjects with onychomycosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DBI-001 Gel
Arm Type
Experimental
Arm Description
Topical application of DBI-001 gel on foot/feet affected with onychomycosis.
Arm Title
DBI-002 Gel
Arm Type
Experimental
Arm Description
Topical application of DBI-002 gel on foot/feet affected with onychomycosis.
Arm Title
Aqueous Gel
Arm Type
Placebo Comparator
Arm Description
Topical application of aqueous gel on foot/feet affected with onychomycosis.
Intervention Type
Biological
Intervention Name(s)
DBI-001
Intervention Description
Topically administered
Intervention Type
Biological
Intervention Name(s)
DBI-002
Intervention Description
Topically administered
Intervention Type
Biological
Intervention Name(s)
Aqueous Gel
Intervention Description
Topically administered
Primary Outcome Measure Information:
Title
Change in percentage of involved great toenail(s)
Description
Absolute change from Baseline in percent of involved treatment-targeted great toenail(s) at Week 24.
Time Frame
24 weeks of participation
Title
Changes in signs and symptoms of Onychomycosis
Description
Change from baseline in individual signs and symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48 of sites treated with DBI-001 Gel or DBI-002 Gel. The minimum value is 0 and the maximum value is 4.
Time Frame
Baseline through End of Study (up to 48 weeks of participation)
Secondary Outcome Measure Information:
Title
Change in percentage of involved great toenail(s)
Description
Absolute change from Baseline in percent of involved treatment-targeted great toenail(s) at Week 48.
Time Frame
48 weeks of participation
Title
Population with completely clear nail growth
Description
Proportion of subjects with completely clear nail growth of the treatment-targeted great toenail(s) at Weeks 24 and 48 based on measurements from digital images.
Time Frame
48 weeks of participation
Title
Change in Investigator's Static Global Assessment (ISGA)
Description
Change from Baseline in Investigator's Static Global Assessment (ISGA) for the treatment-targeted great toenail(s) at Weeks 24 and 48. The minimum value of ISGA is 0 and the maximum value is 4.
Time Frame
48 weeks of participation
Title
Length of new clear nail growth
Description
Length in mm of new clear nail growth based on measurements from digital images at Weeks 24 and 48 of treatment-targeted great toenail(s).
Time Frame
48 weeks of participation
Title
Molecular diagnostic quantitative polymerase chain reaction (qPCR) and whole genome sequencing (WGS) comparison of DBI-001 Gel, DBI-002 Gel and Aqueous Gel on the impact of T. rubrum levels
Description
Antimicrobial efficacy and microbiome community analysis
Time Frame
48 weeks of participation
Title
Change in colony forming units after using DBI-001 Gel or DBI-002 Gel or Aqueous Gel at Weeks 24 and 48
Description
Antimicrobial efficacy
Time Frame
48 weeks of participation
Title
Evaluate the presence of DBI-001, DBI-002 based on qPCR and WGS and Weeks 24 and 48
Description
Antimicrobial efficacy and microbiome community analysis
Time Frame
48 weeks of participation
Title
Evaluate the effect of DBI-001 Gel and DBI-002 Gel on the change in relative abundance and diversity of the cutaneous microbiome of the great toenail(s) from Screening to Weeks 24 and 48 as measured by WGS
Description
Antimicrobial efficacy
Time Frame
48 weeks of participation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 to 50 years of age, inclusive, at Screening
Willing to abstain from all cosmetic activities involving the toenails during the entire course of the study
Distal subungual onychomycosis defined as a great toenail with onycholysis and thickening of the nail bed with keratinous material
Willing to have his/her treatment-targeted great toenail(s) clipped to remove onycholytic nail plate at each visit
At least one treatment-targeted great toenail must have at least 6 mm of clear nail from the proximal nail fold to the proximal limit of disease and, after trimming to within 1mm distal nail groove, have at least 3mm of involved nail from distal nail groove to proximal limit of disease
Confirmed presence of microorganisms of interest by KOH and qPCR at Screening
The affected treatment-targeted great toenail(s) is capable of re-growth as documented by subject self-reported history of clipping nails at least monthly
Exclusion Criteria:
Positive urine pregnancy test, pregnant, lactating, or female of childbearing potential who does not agree to use an active method of birth control for the duration of the study
Any dermatological conditions that could interfere with clinical evaluations
Great toenails with only superficial white onychomycosis, any evidence of subungual mycetoma as evidenced by yellow or white spikes, or any evidence of proximal onychomycosis
Any underlying disease(s) or other dermatological condition(s) that requires the use of interfering topical or systemic therapy, with the exception of certain protocol-specified that require a defined washout period for eligibility
Treatment of any type of cancer within the last 6 months, with the exception of superficial skin cancers such as basal cell carcinoma and squamous cell carcinoma
History of any significant internal disease which contraindicates the use of live microbiome
History of failing oral or prescription topical treatment for onychomycosis
A history of current episode of onychomycosis present for more than 3 years
Nail or anatomic abnormalities of the target great toenail(s)
AIDS or AIDS-related complex by medical history
History of current street drug or alcohol abuse, or street drug or alcohol abuse within the past year
Subjects known or suspected to be taking immune suppressive medications or subjects who are immunosuppressed
Subjects with poorly controlled diabetes mellitus requiring medical intervention/treatment
Subjects with peripheral vascular disease based on medical history
Subjects who have participated in any other trial of an investigational drug or device within 60 days prior to enrollment or participation in a research study concurrent with this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma Taylor, M.D.
Organizational Affiliation
DermBiont, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
T. Joseph Raoof MD, Inc./Encino Research Center
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Minnesota Clinical Study Center
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Facility Name
Oregon Dermatology and Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
DermResearch
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
North Sound Dermatology
City
Mill Creek
State/Province
Washington
ZIP/Postal Code
98012
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Onychomycosis
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