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

NCT05493488 | Unknown Phase 2 FDA Drug

• 1 other identifier: CT-210
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

This is a randomized, observer blinded, Aqueous Gel-controlled trial examining the effect of daily application for approximately 6-8 days of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel on the subjects with interdigital tinea pedis based on Whole Genome Sequencing (WGS) and Quantitative Polymerase Chain Reaction (qPCR), and comparison between Quantitative Polymerase Chain Reaction (qPCR) and Potassium Hydroxide (KOH) for the presence of Trichophyton rubrum (T.rubrum) as well as signs and symptoms and local tolerability and toxicity on treated sites in subjects.

Conditions

Tinea Pedis

Outcome Measures

Primary Outcomes (1)

• Change in abundance of T. rubrum based on Quantitative Polymerase Chain Reaction (qPCR)

  Change in abundance of T. rubrum at baseline, day 7 and day 14

  14 days of participation

Secondary Outcomes (9)

• Number of participants with treatment-related adverse events

  14 days of participation

• Changes in signs and symptoms of T. Pedis

  14 days of participation

• Changes in the signs and symptoms and Investigators Static Global Assessment (ISGA) of Tinea Pedis

  14 days of participation

• Change in abundance of T. rubrum based on qPCR and WGS

  14 days of participation

• Molecular diagnostic qPCR and WGS comparison of DBI-001 Gel, DBI-002 Gel and Aqueous Gel

  14 days of participation

Study Arms (3)

DBI-001 Gel

ACTIVE COMPARATOR

Topical application of DBI-001 Gel on foot/feet affected with tinea pedis

Biological: DBI-001 Gel

DBI-002 Gel

ACTIVE COMPARATOR

Topical application of DBI-002 Gel on foot/feet affected with tinea pedis

Biological: DBI-002 Gel

Aqueous Gel

PLACEBO COMPARATOR

Topical application of Aqueous Gel on foot/feet affected with tinea pedis

Biological: Aqueous Gel

Interventions

DBI-001 Gel BIOLOGICAL

Topical application of DBI-001 gel on foot/feet affected with tinea pedis

DBI-001 Gel

DBI-002 Gel BIOLOGICAL

Topical application of DBI-002 gel on foot/feet affected with tinea pedis

DBI-002 Gel

Aqueous Gel BIOLOGICAL

Topical application of Aqueous gel on foot/feet affected with tinea pedis

Aqueous Gel

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand, agree to, and sign the study Informed Consent
• A signed Health Information Portability and Accountability Act (HIPAA) authorization form which permits the use and disclosure of the subject's individually identifiable health information.
• Male or Female Subjects of any race 18-65 years of age.
• Subjects with a clinical diagnosis of interdigital T. pedis.
• Investigator confirmed diagnosis by a positive T. rubrum potassium hydroxide (KOH) wet mount at Screening at the investigative site.
• A quantifiable level of T. rubrum based on Sponsor laboratory qPCR from the sample obtained at the Screening visit.
• The sum of the clinical signs and symptoms scores of at least one web space (Target web space) is at least 4 using the Grading of Signs and Symptoms of T. pedis including a minimum score of 2 for erythema AND a minimum score of 2 for either scaling/fissures or pruritus/burning (on a scale of 0-3, where 2 indicates moderate severity).
• Target web space(s) should have an adequate amount of leading-edge scale to provide enough scale sampling for KOH.

You may not qualify if:

• Women who are pregnant, planning a pregnancy, breastfeeding or have a positive pregnancy test at screening.
• Any dermatological conditions that could interfere with clinical evaluations
• The clinical diagnosis of moccasin T. pedis.
• Subjects with gram negative interdigital tinea pedis based on a clinical diagnosis: Gram-negative athlete's foot - the interspace is foul smelling, whitish, painful, strongly macerated, and hyperkeratotic with erosions, exudation, and intense inflammation and often disabling.
• Any underlying disease(s) or other dermatological condition that requires the use of interfering topical or systemic therapy.
• Subjects with concurrent use of any of the following topical preparations who have not completed the specified washout period(s) for the following topical medications applied to the foot at the time of the Screening visit:
• Washout of 1 week prior to the screening visit for topical astringents and abrasives (e.g., Burrow's solution), Vicks VapoRub, tea tree oil)
• Washout of 2 weeks prior to the screening visit for topical antibiotics and antifungal on the feet (e.g., Neomycin, Miconazole, Clotrimazole, Terbinafine)
• Washout of 4 weeks prior to the screening visit for the topical Anti-inflammatories, corticosteroids, topical immunomodulators on the feet (e.g., Pimecrolimus, Tacrolimus)
• Subjects with concurrent use of any of the following systemic medications who have not completed the specified washout period(s) for the following systemic medications at the time of the Screening visit:
• Washout of 4 weeks prior to the screening visit for the systemic corticosteroids (including intramuscular injections) (e.g., Triamcinolone acetonide)
• Washout of 4 weeks prior to the screening visit for the systemic antibiotics (e.g., Tetracycline, Cephalosporins, etc.) and/or Antifungal agents (e.g., Fluconazole, Itraconazole, Terbinafine, etc.)
• Washout of 4 weeks prior to the screening visit for the systemic immunomodulators (e.g., Cyclophosphamide, Azathioprine, Biologicals-Monoclonal Antibodies)
• Treatment of any type of cancer within the last 6 months except for superficial skin cancers such as basal cell carcinoma and squamous cell carcinoma.
• History of any significant internal disease which contraindicates use of a live microbiome (e.g., leukemia, liver failure, cardiovascular disease).

Sponsors & Collaborators

• DermBiont, Inc.: lead

Study Sites (2)

Oregon Dermatology and Research

Portland, Oregon, 97210, United States

Location

Premier Clinical Research

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Tinea Pedis

Interventions

BANG polymer gel

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Foot Dermatoses; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pruritus; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emma Taylor, Ph.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 26, 2022
• First Posted: August 9, 2022
• Study Start: September 8, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 14, 2023

Record last verified: 2022-09

Locations

US (2)