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

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 Interdigital Tinea Pedis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Tinea Pedis
• Intervention / Treatment: Biological: DBI-001 Gel; Biological: DBI-002 Gel; Biological: Aqueous Gel

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology and Research
  • Washington
    • Spokane, Washington, United States, 99202
      • Premier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Ability to understand, agree to, and sign the study Informed Consent
2. 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.
3. Male or Female Subjects of any race 18-65 years of age.
4. Subjects with a clinical diagnosis of interdigital T. pedis.
5. Investigator confirmed diagnosis by a positive T. rubrum potassium hydroxide (KOH) wet mount at Screening at the investigative site.
6. A quantifiable level of T. rubrum based on Sponsor laboratory qPCR from the sample obtained at the Screening visit.
7. 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).
8. Target web space(s) should have an adequate amount of leading-edge scale to provide enough scale sampling for KOH.

Exclusion Criteria:

1. Women who are pregnant, planning a pregnancy, breastfeeding or have a positive pregnancy test at screening.
2. Any dermatological conditions that could interfere with clinical evaluations
3. The clinical diagnosis of moccasin T. pedis.
4. 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.
5. Any underlying disease(s) or other dermatological condition that requires the use of interfering topical or systemic therapy.

6. 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:

   1. Washout of 1 week prior to the screening visit for topical astringents and abrasives (e.g., Burrow's solution), Vicks VapoRub, tea tree oil)
   2. Washout of 2 weeks prior to the screening visit for topical antibiotics and antifungal on the feet (e.g., Neomycin, Miconazole, Clotrimazole, Terbinafine)
   3. Washout of 4 weeks prior to the screening visit for the topical Anti-inflammatories, corticosteroids, topical immunomodulators on the feet (e.g., Pimecrolimus, Tacrolimus)

7. 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:

   1. Washout of 4 weeks prior to the screening visit for the systemic corticosteroids (including intramuscular injections) (e.g., Triamcinolone acetonide)
   2. 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.)
   3. Washout of 4 weeks prior to the screening visit for the systemic immunomodulators (e.g., Cyclophosphamide, Azathioprine, Biologicals-Monoclonal Antibodies)
8. 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.
9. History of any significant internal disease which contraindicates use of a live microbiome (e.g., leukemia, liver failure, cardiovascular disease).
10. Subjects who are known to be allergic to any of the Test article(s) or any components in the test article(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure.
11. AIDS or AIDS related complex by medical history.
12. History of current street drug or alcohol abuse, or street drug or alcohol abuse within the past year.
13. Known or suspected immune suppressive medications or diseases.
14. Subjects with poorly controlled diabetes mellitus Type I or II requiring medical intervention/treatment.
15. Peripheral vascular disease based on medical history.
16. Any subject not able to meet the study attendance requirements.
17. Subjects who have participated in any other trial of an investigational drug or device within 30 days prior to enrollment or participation in a research study concurrent with this study.
18. Use of any orthopedic appliance (e.g., cast, soft cast, splint) on either foot or ankle, or surgery of either foot or ankle within 90 days of the Screening visit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: DBI-001 Gel; Topical application of DBI-001 Gel on foot/feet affected with tinea pedis	Biological: DBI-001 Gel; Topical application of DBI-001 gel on foot/feet affected with tinea pedis
ACTIVE_COMPARATOR: DBI-002 Gel; Topical application of DBI-002 Gel on foot/feet affected with tinea pedis	Biological: DBI-002 Gel; Topical application of DBI-002 gel on foot/feet affected with tinea pedis
PLACEBO_COMPARATOR: Aqueous Gel; Topical application of Aqueous Gel on foot/feet affected with tinea pedis	Biological: Aqueous Gel; Topical application of Aqueous gel on foot/feet affected with tinea pedis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events	Safety	14 days of participation
Changes in signs and symptoms of T. Pedis	Change from baseline in individual signs and symptoms of Tinea Pedis at days 7 and 14 of sites treated with DBI-001 Gel, DBI-002 Gel, or Aqueous Gel. The minimum value is 0 and the maximum value is 3 the subject's self reported observation on local tolerability.	14 days of participation
Changes in the signs and symptoms and Investigators Static Global Assessment (ISGA) of Tinea Pedis	Changes from Baseline in signs and symptoms and ISGA at Days 7 and 14	14 days of participation
Change in abundance of T. rubrum based on qPCR and WGS	Antimicrobial efficacy	14 days of participation
Molecular diagnostic qPCR and WGS comparison of DBI-001 Gel, DBI-002 Gel and Aqueous Gel	Antimicrobial efficacy and microbiome community analysis	14 days of participation
Bacterial culture comparison of DBI-001 Gel, DBI-002 Gel and Aqueous Gel	Antimicrobial efficacy and microbiome community analysis	14 days of participation
Increase or decrease of colony forming units after DBI-001 Gel, DBI-002 Gel application	Antimicrobial efficacy	14 days of participation
Correlation between levels of DBI-001 Gel, DBI-002 Gel and abundance of T. rubrum based on qPCR	Antimicrobial efficacy	14 days of participation
Correlation between qPCR quantification and KOH for presence of T. rubrum at screening	Compare sensitivity and specificity of qPCR analysis and KOH for presence of T. rubrum at Screening	28 days from screening

Collaborators and Investigators

• Sponsor: DermBiont, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 8, 2022
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: August 5, 2022
• First Posted (ACTUAL): August 9, 2022

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Foot Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Skin Manifestations; Dermatomycoses; Foot Dermatoses; Pruritus; Tinea; Tinea Pedis
• Other Study ID Numbers: CT-210

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No