Atopic DermatitisPhase 2NCT04192513
Observer-Blinded Dose Escalating, Single Dose to Study Safety and Antimicrobial Efficacy of Gel vs. Placebo
A Phase 2 study testing J. lividum in people with Atopic Dermatitis, run by DermBiont, Inc. at 1 site in Dominican Republic.
Trial summary
A Randomized, Observer-Blinded, Vehicle Controlled, Single Dose, Dose Escalating, Single Application Within-patient Bilateral Comparison. The goal is to determine the safety and tolerability of DBI-001 Gel vs. Placebo in Adults with Atopic Dermatitis (AD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- J. lividum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteDominican Republic
- Study dates
- 20 May 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:
- Ability to understand, agree to, and sign the study Informed Consent. If the patient is unable to provide consent for him/herself, the patient's legally authorized representative may provide written consent.
- 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.
- Physician diagnosed clinically stable Atopic Dermatitis according to the criteria of Hanifin and Rajka affecting ≤25% of total BSA with comparable bilateral antecubital or popliteal lesions. Each lesion must have an ADSI ≥6 with a difference between the lesions of ≤1. It will be in the opinion of the Investigator whether the lesions are clinically stable.
- Moderate to heavy growth of S. aureus based on culture at the time of screening.
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- Willingness to discontinue use of other Atopic Dermatitis treatment for the duration of the study unless specifically permitted by the Investigator.
- Women of child-bearing potential must:
- Have negative urine pregnancy tests prior to study treatment to rule out pregnancy, and
- 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.
- Willingness not to wash the antecubital lesions on both arms, or the popliteal lesions on both legs, with soap and water from the time of test article application at baseline visit until after the completion of the Day 2 visit.
- Allow digital photos of arms or legs to be taken and stored.
Who cannot join
- 1. Women who are pregnant, planning a pregnancy, or breastfeeding or have a positive pregnancy test at the site.
- 2. Any dermatological conditions that could interfere with clinical evaluations or any disease state or physical condition which might expose the patient to an unacceptable risk by study participation.
- 3. Any underlying disease(s) or other dermatological conditions that require the use of exclusionary topical or systemic therapy (see Points 5 and 6).
- 4. Known sensitivity to any of the components of the study medication. 5. Washout of 4 weeks for topical treatments used on the six designated sites, including but not limited to: antibacterial products, anti-inflammatories (e.g. corticosteroids, tacrolimus, Pimecrolimus). Other than the six sites on the arms or legs, topical mediations may be used before/during the duration of the study.
- 6. Willing not to apply any prescription or over the counter topical product on the selected designated sites on arms or legs.
- 7. Washout of 4 weeks for systemic treatments for AD, including but not limited to corticosteroids (oral or intramuscular injections), systemic immunomodulators or immunosuppressive (e.g., methotrexate, cyclosporine, hydroxychloroquine), antibiotics (oral or injected, if required to treat a medical condition short duration of oral antibiotics (≤10 days) are permitted after randomization).
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- 8. Spontaneously improving or rapidly deteriorating dermatitis of the antecubital fossa or popliteal fossa.
- 9. Netherton's syndrome or other genodermatoses that result in defective epidermal barrier function.
- 10. Washout of 4 weeks for bleach baths. 11. Washout of 4 weeks for phototherapy.
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: A Randomized, Observer-Blinded, Vehicle Controlled, Single Dose, Dose Escalating, Single Application Within-patient Bilateral Comparison to Study the Safety and Antimicrobial Efficacy of DBI-001 Gel Vs. Placebo
A Randomized, Observer-Blinded, Vehicle Controlled, Single Dose, Dose Escalating, Single Application Within-patient Bilateral Comparison. The goal is to determine the safety and tolerability of DBI-001 Gel vs. Placebo in Adults with Atopic Dermatitis (AD).
Read the detailed description
A Randomized, Observer-Blinded, Vehicle Controlled, Single Dose, Dose Escalating, Single Application Within-patient Bilateral Comparison. The goal is to determine the safety and tolerability of DBI-001 Gel vs. Placebo in Adults with Atopic Dermatitis and to determine the antibacterial effect of a single application of DBI-001 Gel on the abundance of S. aureus.
Tolerability will be evaluated through assessment of disease state severity and signs and symptoms of local tolerability (pain / burning / stinging, pruritus, erythema, edema, and scabbing / crusting) and review of adverse events. Any local skin reaction that requires use of a concomitant therapy or study discontinuation will be reported.
- Conditions
- Atopic Dermatitis
- Being tested
- J. lividum
- Keywords
- Atopic Dermatitis, S. aureus
- Medical subject headings
- Dermatitis, Atopic, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
J. lividumDrug
Also called Janthinobacterium lividum
Investigational Product
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 DBI-001 Gel and placebo | Active comparator | Cohort 1 DBI-001 Gel with low dose CFU's of J. lividum and placebo Receives: Drug: J. lividum |
| Cohort 2 mid dose DBI-001 Gel and placebo | Active comparator | Cohort 2 DBI-001 Gel with mid dose CFU's of J. lividum and placebo Receives: Drug: J. lividum |
| Cohort 3 high dose DBI-001 Gel and placebo | Active comparator | Cohort 3 DBI-001 Gel with high dose CFU's of J. lividum. Drug: J. lividum and placebo Receives: Drug: J. lividum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Local Tolerability Based on Scale Listed
Tolerability will be evaluated through assessment of local signs and symptoms. Scoring for burning, stinging, pruritus, erythema, edema, scabbing or crusting. : 0+ none (complete absence), 1=slight (slight), 2=moderate (definitely present), 3=severe (marked, intense).
Measured: Baseline (Day 1) and 14
Secondary outcomes (1)
Change in S. aureus abundance
Change in the abundance of S. aureus following a single application of DBI-001 Gel.
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start20 May 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Why it stopped: Covid-19 has shut the clinic indefinitely
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Sequential
- Model description
- A randomized, observer-blinded, vehicle controlled, single dose application, dose escalating bilateral comparison study of DBI-001 Gel vs. Placebo in the patients with Atopic Dermatitis (AD) affecting the antecubital areas and/or posterior popliteal areas. Subjects meeting the inclusion/exclusion criteria and having moderate to heavy growth of S. aureus from a sample collected at screening from an area of dermatitis on at least one arm or at least one leg will be enrolled into the study. Microbiological samples will be collected from all the designated sites on the arms or leg and all subjects will be treated with a single application of the assigned test articles applied by the unblinded treating investigator at the baseline visit.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 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
- NCT04192513
- Sponsor's protocol ID
- DBI-203
- Status last verified
- Jul 2020
- First submitted
- 2 Dec 2019
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- A Randomized, Observer-Blinded, Vehicle Controlled, Single Dose, Dose Escalating, Single Application Within-patient Bilateral Comparison to Study the Safety and Antimicrobial Efficacy of DBI-001 Gel Vs. Placebo
- ClinicalTrials.gov ID
- NCT04192513
- Acronym / sponsor ID
- DBI-203
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, S. aureus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid-19 has shut the clinic indefinitely
- Enrolment
- 9 participants (actual)
- Lead sponsor
- DermBiont, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 May 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 10 Dec 2019 (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.
A Randomized, Observer-Blinded, Vehicle Controlled, Single Dose, Dose Escalating, Single Application Within-patient Bilateral Comparison. The goal is to determine the safety and tolerability of DBI-001 Gel vs. Placebo in Adults with Atopic Dermatitis (AD).
Detailed description
A Randomized, Observer-Blinded, Vehicle Controlled, Single Dose, Dose Escalating, Single Application Within-patient Bilateral Comparison. The goal is to determine the safety and tolerability of DBI-001 Gel vs. Placebo in Adults with Atopic Dermatitis and to determine the antibacterial effect of a single application of DBI-001 Gel on the abundance of S. aureus.
Tolerability will be evaluated through assessment of disease state severity and signs and symptoms of local tolerability (pain / burning / stinging, pruritus, erythema, edema, and scabbing / crusting) and review of adverse events. Any local skin reaction that requires use of a concomitant therapy or study discontinuation will be reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized, observer-blinded, vehicle controlled, single dose application, dose escalating bilateral comparison study of DBI-001 Gel vs. Placebo in the patients with Atopic Dermatitis (AD) affecting the antecubital areas and/or posterior popliteal areas. Subjects meeting the inclusion/exclusion criteria and having moderate to heavy growth of S. aureus from a sample collected at screening from an area of dermatitis on at least one arm or at least one leg will be enrolled into the study. Microbiological samples will be collected from all the designated sites on the arms or leg and all subjects will be treated with a single application of the assigned test articles applied by the unblinded treating investigator at the baseline visit.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 DBI-001 Gel and placebo | Active comparator | Drug: J. lividumCohort 1 DBI-001 Gel with low dose CFU's of J. lividum and placebo |
| Cohort 2 mid dose DBI-001 Gel and placebo | Active comparator | Drug: J. lividumCohort 2 DBI-001 Gel with mid dose CFU's of J. lividum and placebo |
| Cohort 3 high dose DBI-001 Gel and placebo | Active comparator | Drug: J. lividumCohort 3 DBI-001 Gel with high dose CFU's of J. lividum. Drug: J. lividum and placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects must meet all of the following criteria to be included in the study:
Key exclusion criteria (9 listed)
- 1. Women who are pregnant, planning a pregnancy, or breastfeeding or have a positive pregnancy test at the site.
- 2. Any dermatological conditions that could interfere with clinical evaluations or any disease state or physical condition which might expose the patient to an unacceptable risk by study participation.
- 3. Any underlying disease(s) or other dermatological conditions that require the use of exclusionary topical or systemic therapy (see Points 5 and 6).
- 4. Known sensitivity to any of the components of the study medication. 5. Washout of 4 weeks for topical treatments used on the six designated sites, including but not limited to: antibacterial products, anti-inflammatories (e.g. corticosteroids, tacrolimus, Pimecrolimus). Other than the six sites on the arms or legs, topical mediations may be used before/during the duration of the study.
- 6. Willing not to apply any prescription or over the counter topical product on the selected designated sites on arms or legs.
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 |
|---|---|---|
| J. lividumAlso: Janthinobacterium lividumInvestigational Product | Drug | Cohort 1 DBI-001 Gel and placebo, Cohort 2 mid dose DBI-001 Gel and placebo, Cohort 3 high dose DBI-001 Gel and placebo |
Primary outcome
Change in Local Tolerability Based on Scale Listed
Time frame: Baseline (Day 1) and 14
Tolerability will be evaluated through assessment of local signs and symptoms. Scoring for burning, stinging, pruritus, erythema, edema, scabbing or crusting. : 0+ none (complete absence), 1=slight (slight), 2=moderate (definitely present), 3=severe (marked, intense).
1 secondary outcome
Change in S. aureus abundance
Time frame: 14 Days
Results and safety
The study was stopped early (reason given: Covid-19 has shut the clinic indefinitely). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: No
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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.
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 J. lividum in people with Atopic Dermatitis, 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 12 inclusion and 9 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. 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 indefinitely). 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 Local Tolerability Based on Scale Listed (time frame: Baseline (Day 1) and 14). 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.