Tinea PedisPhase 2NCT05493488
A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Tinea Pedis
A Phase 2 study testing DBI-001 Gel, DBI-002 Gel and Aqueous Gel in people with Tinea Pedis, run by DermBiont, Inc. at 2 sites in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tinea Pedis
- What is being tested?
- DBI-001 Gel, DBI-002 Gel and Aqueous Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Sep 2022to 31 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 24Show fewer
- 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).
- 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.
- 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.
- Known or suspected immune suppressive medications or diseases.
- Subjects with poorly controlled diabetes mellitus Type I or II requiring medical intervention/treatment.
- Peripheral vascular disease based on medical history.
- Any subject not able to meet the study attendance requirements.
- 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.
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Oregon Dermatology and Research
Portland, Oregon, 97210
Premier Clinical Research
Spokane, Washington, 99202
About this study
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 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.
- Conditions
- Tinea Pedis
- Being tested
- DBI-001 Gel, DBI-002 Gel, Aqueous Gel
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBI-001 GelBiological
Topical application of DBI-001 gel on foot/feet affected with tinea pedis
DBI-002 GelBiological
Topical application of DBI-002 gel on foot/feet affected with tinea pedis
Aqueous GelBiological
Topical application of Aqueous gel on foot/feet affected with tinea pedis
| Study group | Role | What they receive |
|---|---|---|
| DBI-001 Gel | Active comparator | Topical application of DBI-001 Gel on foot/feet affected with tinea pedis Receives: Biological: DBI-001 Gel |
| DBI-002 Gel | Active comparator | Topical application of DBI-002 Gel on foot/feet affected with tinea pedis Receives: Biological: DBI-002 Gel |
| Aqueous Gel | Placebo comparator | Topical application of Aqueous Gel on foot/feet affected with tinea pedis Receives: Biological: Aqueous Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days of participation
Secondary outcomes (9)
Number of participants with treatment-related adverse events
Safety
Measured: 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.
Measured: 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
Measured: 14 days of participation
Change in abundance of T. rubrum based on qPCR and WGS
Antimicrobial efficacy
Measured: 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
Measured: 14 days of participation
Bacterial culture comparison of DBI-001 Gel, DBI-002 Gel and Aqueous Gel
Antimicrobial efficacy and microbiome community analysis
Measured: 14 days of participation
Increase or decrease of colony forming units after DBI-001 Gel, DBI-002 Gel application
Antimicrobial efficacy
Measured: 14 days of participation
Correlation between levels of DBI-001 Gel, DBI-002 Gel and abundance of T. rubrum based on qPCR
Antimicrobial efficacy
Measured: 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
Measured: 28 days from screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start8 Sep 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinea PedisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DermBiont, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emma Taylor, Ph.D, Study director, DermBiont, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493488
- Sponsor's protocol ID
- CT-210
- Status last verified
- Sep 2022
- First submitted
- 26 Jul 2022
- Last updated
- 14 Feb 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Interdigital Tinea Pedis
- ClinicalTrials.gov ID
- NCT05493488
- Acronym / sponsor ID
- CT-210
- Conditions
- Tinea Pedis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- DermBiont, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DBI-001 Gel | Active comparator | Biological: DBI-001 GelTopical application of DBI-001 Gel on foot/feet affected with tinea pedis |
| DBI-002 Gel | Active comparator | Biological: DBI-002 GelTopical application of DBI-002 Gel on foot/feet affected with tinea pedis |
| Aqueous Gel | Placebo comparator | Biological: Aqueous GelTopical application of Aqueous Gel on foot/feet affected with tinea pedis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBI-001 GelTopical application of DBI-001 gel on foot/feet affected with tinea pedis | Biological | DBI-001 Gel |
| DBI-002 GelTopical application of DBI-002 gel on foot/feet affected with tinea pedis | Biological | DBI-002 Gel |
| Aqueous GelTopical application of Aqueous gel on foot/feet affected with tinea pedis | Biological | Aqueous Gel |
Primary outcome
Change in abundance of T. rubrum based on Quantitative Polymerase Chain Reaction (qPCR)
Time frame: 14 days of participation
Change in abundance of T. rubrum at baseline, day 7 and day 14
9 secondary outcomes
Number of participants with treatment-related adverse events
Time frame: 14 days of participation
Changes in signs and symptoms of T. Pedis
Time frame: 14 days of participation
Changes in the signs and symptoms and Investigators Static Global Assessment (ISGA) of Tinea Pedis
Time frame: 14 days of participation
Change in abundance of T. rubrum based on qPCR and WGS
Time frame: 14 days of participation
Molecular diagnostic qPCR and WGS comparison of DBI-001 Gel, DBI-002 Gel and Aqueous Gel
Time frame: 14 days of participation
Bacterial culture comparison of DBI-001 Gel, DBI-002 Gel and Aqueous Gel
Time frame: 14 days of participation
Increase or decrease of colony forming units after DBI-001 Gel, DBI-002 Gel application
Time frame: 14 days of participation
Correlation between levels of DBI-001 Gel, DBI-002 Gel and abundance of T. rubrum based on qPCR
Time frame: 14 days of participation
Correlation between qPCR quantification and KOH for presence of T. rubrum at screening
Time frame: 28 days from screening
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
Related trials for Tinea Pedis
RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
RecruitingPhase 1
A Phase 1b Study of ZYG24004 in Participants With Tinea Pedis Caused by Dermatophytes
Tinea Pedis
Recruiting
Atmospheric Pressure Cold Plasma for Moderate-to-severe Tinea Pedis
Tinea Pedis
RecruitingPhase 2
Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study
Tinea Pedis
Not yet recruitingObservational study
Sports Nutrition Assessment Program
Diet Habit, Body Weight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Taylor, Ph.D study director
DermBiont, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DBI-001 Gel, DBI-002 Gel and Aqueous Gel in people with Tinea Pedis, run by DermBiont, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in abundance of T. rubrum based on Quantitative Polymerase Chain Reaction (qPCR) (time frame: 14 days of participation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023; AzTrials last refreshed its copy on 8 Nov 2026.