OnychomycosisPhase 2NCT05491603
A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Onychomycosis
A Phase 2 study testing DBI-001, DBI-002 and Aqueous Gel in people with Onychomycosis, run by DermBiont, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- DBI-001, DBI-002 and Aqueous Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2023to 30 Nov 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
DermResearch
Austin, Texas, 78759
T. Joseph Raoof MD, Inc./Encino Research Center
Encino, California, 91436
North Sound Dermatology
Mill Creek, Washington, 98012
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112
Oregon Dermatology and Research Center
Portland, Oregon, 97210
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 Onychomycosis
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
- Being tested
- DBI-001, DBI-002, Aqueous Gel
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBI-001Biological
Topically administered
DBI-002Biological
Topically administered
Aqueous GelBiological
Topically administered
| Study group | Role | What they receive |
|---|---|---|
| DBI-001 Gel | Experimental | Topical application of DBI-001 gel on foot/feet affected with onychomycosis. Receives: Biological: DBI-001 |
| DBI-002 Gel | Experimental | Topical application of DBI-002 gel on foot/feet affected with onychomycosis. Receives: Biological: DBI-002 |
| Aqueous Gel | Placebo comparator | Topical application of aqueous gel on foot/feet affected with onychomycosis. Receives: Biological: Aqueous Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percentage of involved great toenail(s)
Absolute change from Baseline in percent of involved treatment-targeted great toenail(s) at Week 24.
Measured: 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.
Measured: Baseline through End of Study (up to 48 weeks of participation)
Secondary outcomes (8)
Change in percentage of involved great toenail(s)
Absolute change from Baseline in percent of involved treatment-targeted great toenail(s) at Week 48.
Measured: 48 weeks of participation
Population with completely clear nail growth
Proportion of subjects with completely clear nail growth of the treatment-targeted great toenail(s) at Weeks 24 and 48 based on measurements from digital images.
Measured: 48 weeks of participation
Change in Investigator's Static Global Assessment (ISGA)
Change from Baseline in Investigator's Static Global Assessment (ISGA) for the treatment-targeted great toenail(s) at Weeks 24 and 48. The minimum value of ISGA is 0 and the maximum value is 4.
Measured: 48 weeks of participation
Length of new clear nail growth
Length in mm of new clear nail growth based on measurements from digital images at Weeks 24 and 48 of treatment-targeted great toenail(s).
Measured: 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
Antimicrobial efficacy and microbiome community analysis
Measured: 48 weeks of participation
Change in colony forming units after using DBI-001 Gel or DBI-002 Gel or Aqueous Gel at Weeks 24 and 48
Antimicrobial efficacy
Measured: 48 weeks of participation
Evaluate the presence of DBI-001, DBI-002 based on qPCR and WGS and Weeks 24 and 48
Antimicrobial efficacy and microbiome community analysis
Measured: 48 weeks of participation
Evaluate the effect of DBI-001 Gel and DBI-002 Gel on the change in relative abundance and diversity of the cutaneous microbiome of the great toenail(s) from Screening to Weeks 24 and 48 as measured by WGS
Antimicrobial efficacy
Measured: 48 weeks of participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study startNov 2023 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Why it stopped: Suspended: Study halted prematurely but potentially will resume. Sponsor suspension, and not due to safety or site-related matters.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnychomycosisStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DermBiont, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emma Taylor, M.D., Study director, DermBiont, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491603
- Sponsor's protocol ID
- CT-206
- Status last verified
- Feb 2023
- First submitted
- 28 Jul 2022
- Last updated
- 7 Sep 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 7 Sep 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 Onychomycosis
- ClinicalTrials.gov ID
- NCT05491603
- Acronym / sponsor ID
- CT-206
- Conditions
- Onychomycosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Suspended: Study halted prematurely but potentially will resume. Sponsor suspension, and not due to safety or site-related matters.
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- DermBiont, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2023 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 8 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 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.
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 | Experimental | Biological: DBI-001Topical application of DBI-001 gel on foot/feet affected with onychomycosis. |
| DBI-002 Gel | Experimental | Biological: DBI-002Topical application of DBI-002 gel on foot/feet affected with onychomycosis. |
| Aqueous Gel | Placebo comparator | Biological: Aqueous GelTopical application of aqueous gel on foot/feet affected with onychomycosis. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18 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
Key exclusion criteria (15 listed)
- 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
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-001Topically administered | Biological | DBI-001 Gel |
| DBI-002Topically administered | Biological | DBI-002 Gel |
| Aqueous GelTopically administered | Biological | Aqueous Gel |
Primary outcome
Change in percentage of involved great toenail(s)
Time frame: 24 weeks of participation
Absolute change from Baseline in percent of involved treatment-targeted great toenail(s) at Week 24.
Changes in signs and symptoms of Onychomycosis
Time frame: Baseline through End of Study (up to 48 weeks of participation)
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.
8 secondary outcomes
Change in percentage of involved great toenail(s)
Time frame: 48 weeks of participation
Population with completely clear nail growth
Time frame: 48 weeks of participation
Change in Investigator's Static Global Assessment (ISGA)
Time frame: 48 weeks of participation
Length of new clear nail growth
Time frame: 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
Time frame: 48 weeks of participation
Change in colony forming units after using DBI-001 Gel or DBI-002 Gel or Aqueous Gel at Weeks 24 and 48
Time frame: 48 weeks of participation
Evaluate the presence of DBI-001, DBI-002 based on qPCR and WGS and Weeks 24 and 48
Time frame: 48 weeks of participation
Evaluate the effect of DBI-001 Gel and DBI-002 Gel on the change in relative abundance and diversity of the cutaneous microbiome of the great toenail(s) from Screening to Weeks 24 and 48 as measured by WGS
Time frame: 48 weeks of participation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
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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, M.D. study director
DermBiont, Inc.
5 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, DBI-002 and Aqueous Gel in people with Onychomycosis, run by DermBiont, Inc. at 5 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 7 inclusion and 15 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: paused, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 percentage of involved great toenail(s) (time frame: 24 weeks of participation). The study lists 2 primary outcomes in all. 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 7 Sep 2023.