A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Onychomycosis
NCT ID: NCT05491603
Last Updated: 2023-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE2
60 participants
INTERVENTIONAL
2023-11-30
2023-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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DBI-001 Gel
Topical application of DBI-001 gel on foot/feet affected with onychomycosis.
DBI-001
Topically administered
DBI-002 Gel
Topical application of DBI-002 gel on foot/feet affected with onychomycosis.
DBI-002
Topically administered
Aqueous Gel
Topical application of aqueous gel on foot/feet affected with onychomycosis.
Aqueous Gel
Topically administered
Interventions
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DBI-001
Topically administered
DBI-002
Topically administered
Aqueous Gel
Topically administered
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
No
Sponsors
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DermBiont, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Emma Taylor, M.D.
Role: STUDY_DIRECTOR
DermBiont, Inc.
Locations
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T. Joseph Raoof MD, Inc./Encino Research Center
Encino, California, United States
Minnesota Clinical Study Center
New Brighton, Minnesota, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
DermResearch
Austin, Texas, United States
North Sound Dermatology
Mill Creek, Washington, United States
Countries
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Other Identifiers
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CT-206
Identifier Type: -
Identifier Source: org_study_id
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