A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Onychomycosis

NCT05491603 | Suspended Phase 2 FDA Drug

• 1 other identifier: CT-206
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

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.

Conditions

Onychomycosis

Outcome Measures

Primary Outcomes (2)

• Change in percentage of involved great toenail(s)

  Absolute change from Baseline in percent of involved treatment-targeted great toenail(s) at Week 24.

  24 weeks of participation

• 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.

  Baseline through End of Study (up to 48 weeks of participation)

Secondary Outcomes (8)

• Change in percentage of involved great toenail(s)

  48 weeks of participation

• Population with completely clear nail growth

  48 weeks of participation

• Change in Investigator's Static Global Assessment (ISGA)

  48 weeks of participation

• Length of new clear nail growth

  48 weeks of participation

• 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

  48 weeks of participation

Study Arms (3)

DBI-001 Gel

EXPERIMENTAL

Topical application of DBI-001 gel on foot/feet affected with onychomycosis.

Biological: DBI-001

DBI-002 Gel

EXPERIMENTAL

Topical application of DBI-002 gel on foot/feet affected with onychomycosis.

Biological: DBI-002

Aqueous Gel

PLACEBO COMPARATOR

Topical application of aqueous gel on foot/feet affected with onychomycosis.

Biological: Aqueous Gel

Interventions

DBI-001 BIOLOGICAL

Topically administered

DBI-001 Gel

DBI-002 BIOLOGICAL

Topically administered

DBI-002 Gel

Aqueous Gel BIOLOGICAL

Topically administered

Aqueous Gel

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DermBiont, Inc.: lead

Study Sites (5)

T. Joseph Raoof MD, Inc./Encino Research Center

Encino, California, 91436, United States

Location

Minnesota Clinical Study Center

New Brighton, Minnesota, 55112, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

DermResearch

Austin, Texas, 78759, United States

Location

North Sound Dermatology

Mill Creek, Washington, 98012, United States

Location

MeSH Terms

Conditions

Onychomycosis

Interventions

BANG polymer gel

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Emma Taylor, M.D.

  DermBiont, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 8, 2022
• Study Start: November 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-02

Locations

US (5)