Clinical trial NCT05491603: 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
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Onychomycosis
Lead sponsor: DermBiont, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in percentage of involved great toenail(s)
timeFrame: 24 weeks of participation
measure: Changes in signs and symptoms of Onychomycosis
timeFrame: Baseline through End of Study (up to 48 weeks of participation)
Secondary outcomes:
measure: Change in percentage of involved great toenail(s)
timeFrame: 48 weeks of participation
measure: Population with completely clear nail growth
timeFrame: 48 weeks of participation
measure: Change in Investigator's Static Global Assessment (ISGA)
timeFrame: 48 weeks of participation
measure: Length of new clear nail growth
timeFrame: 48 weeks of participation
measure: 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
timeFrame: 48 weeks of participation
measure: Change in colony forming units after using DBI-001 Gel or DBI-002 Gel or Aqueous Gel at Weeks 24 and 48
timeFrame: 48 weeks of participation
measure: Evaluate the presence of DBI-001, DBI-002 based on qPCR and WGS and Weeks 24 and 48
timeFrame: 48 weeks of participation
measure: 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
timeFrame: 48 weeks of participation
Other outcomes:
Locations:
city: Encino
country: United States
facility: T. Joseph Raoof MD, Inc./Encino Research Center
state: California
city: New Brighton
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Austin
country: United States
facility: DermResearch
state: Texas
city: Mill Creek
country: United States
facility: North Sound Dermatology
state: Washington
Study officials:
affiliation: DermBiont, Inc.
name: Emma Taylor, M.D.
role: STUDY_DIRECTOR
References: