Interdigital Tinea PedisPhase 2NCT04315051
A Trial of Safety/Efficacy of Test Article in Patients With Interdigital T. Pedis
A Phase 2 study testing Cohort 1 J. Lividum in people with Interdigital Tinea Pedis, run by DermBiont, Inc. at 1 site in Dominican Republic.
Trial summary
Placebo Controlled Trial of the Safety and Efficacy of DBI-001 in Patients with Interdigital Tinea pedis (T. pedis) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Interdigital Tinea Pedis
- What is being tested?
- Cohort 1 J. Lividum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteDominican Republic
- Study dates
- 12 Sep 2019to 30 Jun 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be included in the study:
- A signed approved informed consent form by Institutional Review Board/Independent Ethics Committee.
- A signed Health Information Portability and Accountability Act (HIPAA) authorization form which permits the use and disclosure of subject's individually identifiable health information.
- Male or Female Subjects of any race 18 years of age and older.
- Women patients of child-bearing potential must: a. Have negative urine pregnancy tests prior to study treatment to rule out pregnancy, and b. Use at least one method of birth control that results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner for the duration of study participation.
- Subjects with a clinical diagnosis of interdigital T. pedis T. pedis interdigital defined as lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot (the non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin).
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- Provisionally confirmed diagnosis at screening by a positive potassium hydroxide (KOH) wet mount at the clinical site.
- A positive dermatophyte culture 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 at least 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 should have adequate amount of leading-edge scale to provide enough scale for KOH, fungal culture and molecular diagnostics.
Who cannot join
- Subjects with the following will be excluded from this study:
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- Females who are pregnant, planning a pregnancy, breastfeeding or have a positive pregnancy test at the site.
- Any dermatological conditions that could interfere with clinical evaluations.
- The clinical diagnosis of moccasin T. pedis.
- Any underlying disease(s) or some other dermatological condition that requires the use of interfering topical or systemic therapy.
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- Subjects that have not undergone the specified washout period(s) or subjects who require the concurrent use of specific topical medications applied to the foot.
- Subjects that have not undergone the washout periods for systemic medications or who require the use of specific systemic medications.
- Treatment of any type of cancer within the last 6 months.
- History of any significant internal disease (which contraindicates use of 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.
- Known or suspected immune suppressive medications or diseases.
- Diabetes mellitus Type I or II by medical history.
- 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.
Trial locations and contacts
1 site in 1 country.
Dominican Republic1 site
Instituto Dermatologico y Cirugia de Piel
Santo Domingo
About this study
Official title: Clinical Trial Protocol DBI-204 Double-Blind, Randomized, Placebo Controlled Trial of the Safety and Efficacy of DBI-001 Gel in Patients With Interdigital Tinea Pedis
Placebo Controlled Trial of the Safety and Efficacy of DBI-001 in Patients with Interdigital Tinea pedis (T. pedis)
Read the detailed description
Double-Blind, Randomized, Placebo Controlled Trial of the Safety and Efficacy of DBI-001 Gel in Patients with Interdigital Tinea pedis (T. pedis). The primary objective is to observe the antimicrobial effect of a daily application of DBI-001Gel for 4 weeks in patients with interdigital T. pedis based on the change from culture positive for a dermatophyte to culture negative as determined by routine mycology culture.
- Conditions
- Interdigital Tinea Pedis
- Being tested
- Cohort 1 J. Lividum, Placebo Gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort 1 J. LividumDrug
Subject to apply DBI-001 Gel on each foot covering all web spaces, the plantar and lateral aspects, toes and toenails
Placebo GelOther
Subject to apply Placebo Gel daily on each foot covering all web spaces, the plantar and lateral aspects, toes and toenails.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Gel | Placebo comparator | Placebo gel daily application for 4 weeks Receives: Other: Placebo Gel |
| Cohort 1 | Active comparator | DBI-001 Gel daily application for 4 weeks Receives: Drug: Cohort 1 J. Lividum |
What is being measured
The primary outcome is the main question the study is designed to answer.
From Culture Positive to Culture Negative
Antimicrobial effect. Effect will be measured by change from culture positive for dermatophyte to culture negative as determined by routine mycology culture.
Measured: Baseline (Day 1) to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start12 Sep 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Why it stopped: Covid- 19 has shut the clinic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interdigital 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A Double-Blind, Randomized, Placebo Controlled trial of the Safety and Efficacy of DBI-001 Gel in patients with interdigital T. pedis. Test articles will be applied by subjects once daily at bedtime for a period of four (4) weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- DermBiont, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daisy Blanco, MD, Study director, Instituto Dermatologico y Cirugia de Piel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315051
- Sponsor's protocol ID
- DBI-204
- Status last verified
- Feb 2021
- First submitted
- 12 Mar 2020
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Protocol DBI-204 Double-Blind, Randomized, Placebo Controlled Trial of the Safety and Efficacy of DBI-001 Gel in Patients With Interdigital Tinea Pedis
- ClinicalTrials.gov ID
- NCT04315051
- Acronym / sponsor ID
- DBI-204
- Conditions
- Interdigital Tinea Pedis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid- 19 has shut the clinic
- Enrolment
- 39 participants (actual)
- Lead sponsor
- DermBiont, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Sep 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 19 Mar 2020 (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.
Placebo Controlled Trial of the Safety and Efficacy of DBI-001 in Patients with Interdigital Tinea pedis (T. pedis)
Detailed description
Double-Blind, Randomized, Placebo Controlled Trial of the Safety and Efficacy of DBI-001 Gel in Patients with Interdigital Tinea pedis (T. pedis). The primary objective is to observe the antimicrobial effect of a daily application of DBI-001Gel for 4 weeks in patients with interdigital T. pedis based on the change from culture positive for a dermatophyte to culture negative as determined by routine mycology culture.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Double-Blind, Randomized, Placebo Controlled trial of the Safety and Efficacy of DBI-001 Gel in patients with interdigital T. pedis. Test articles will be applied by subjects once daily at bedtime for a period of four (4) weeks.
| Arm | Type | Receives |
|---|---|---|
| Placebo Gel | Placebo comparator | Other: Placebo GelPlacebo gel daily application for 4 weeks |
| Cohort 1 | Active comparator | Drug: Cohort 1 J. LividumDBI-001 Gel daily application for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects must meet all of the following criteria to be included in the study:
Key exclusion criteria (17 listed)
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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 |
|---|---|---|
| Cohort 1 J. LividumSubject to apply DBI-001 Gel on each foot covering all web spaces, the plantar and lateral aspects, toes and toenails | Drug | Cohort 1 |
| Placebo GelSubject to apply Placebo Gel daily on each foot covering all web spaces, the plantar and lateral aspects, toes and toenails. | Other | Placebo Gel |
Primary outcome
From Culture Positive to Culture Negative
Time frame: Baseline (Day 1) to Day 28
Antimicrobial effect. Effect will be measured by change from culture positive for dermatophyte to culture negative as determined by routine mycology culture.
Results and safety
The study was stopped early (reason given: Covid- 19 has shut the clinic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
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.
Daisy Blanco, MD study director
Instituto Dermatologico y Cirugia de Piel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cohort 1 J. Lividum in people with Interdigital Tinea Pedis, run by DermBiont, Inc. at 1 site in Dominican Republic.
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 10 inclusion and 17 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: stopped early, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Dominican Republic. 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?
The study was stopped early (reason given: Covid- 19 has shut the clinic). 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?
From Culture Positive to Culture Negative (time frame: Baseline (Day 1) to Day 28). 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 18 Jun 2021.