Atopic DermatitisPhase 2NCT05253755
Study the Safety and Efficacy of DBI-001 Gel Versus Aqueous Gel
A Phase 2 study testing DBI-001 and Aqueous gel in people with Atopic Dermatitis, run by DermBiont, Inc. at 3 sites in United States.
Trial summary
The purpose for this study is to assess the Safety and Efficacy of Daily Application for 4 weeks of DBI-001 Gel Versus Aqueous Gel in Subjects with Atopic Dermatitis Read more about this study
- Who is it for?
- Ages 12 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- DBI-001 and Aqueous gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Oct 2021to 9 Sep 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 1. 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.
- 2. A signed Health Information Portability and Accountability Act (HIPAA) authorization form which permits the use and disclosure of subject's individually identifiable health information.
- 3. Male or Female Subjects of any race 12 - 65 years of age.
- 4. Physician diagnosed clinically stable AD according to the criteria of Hanifin and Rajka with symmetrical bilateral target lesions (Hanifin and Rajka 1980). Lesion on each arm or leg must have an Atopic Dermatitis Severity Index (ADSI) ≥6. The 2 sites need to be comparable anatomically symmetrical sites. It will be in the opinion of the Investigator based on subject's medical history whether the lesions are clinically stable.
- 5. Female patients of child-bearing potential must 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.
- 6. Technical ability and willingness to apply test articles during telemedicine visits with the study staff and unsupervised on weekends.
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- 7. Willingness to discontinue use of systemic AD treatments and topical treatments to the target areas for the duration of the study unless specifically permitted by the Investigator.
- 8. Willingness to comply with test site restriction for 12 hours prior to all office visits including the Baseline visit and for 12 hours after each treatment application. These treatment site restrictions include:
- No washing of test sites with any cleansers or soaps at any time from the Baseline visit to completion of the Day 42 Follow up Visit. Water passing over the areas during showering is acceptable.
- No rubbing the test sites with a washcloth, towel, luffas. Pat dry after showering is acceptable.
- No recreational activities in chlorinated or chemically treated water such as swimming pools, hot tubs, and spas.
- No tight or form fitting clothing covering the treatment areas.
- No sunbathing or use of suntan parlors or tanning beds.
- If participating in physical activities resulting in heavy perspiration only pat dry test site areas with towel if needed.
- Any activity that in the opinion of the investigator might alter the quality of the samples collected or risk removal of the test article.
- 9. Willingness to undergo the following washout periods:
- Washout of 2 weeks prior to the Baseline visit for topical treatments used on the two treatment target sites, including but not limited to: antibacterial products, anti-inflammatories (e.g., corticosteroids, tacrolimus, Pimecrolimus). Other than the two sites on the arms or legs, topical medications may be used before/during the duration of the study. Subjects will be provided 1% hydrocortisone for treating non-target areas during the trial.
- Washout of 4 weeks prior to the Baseline visit 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)
- Washout of 2 weeks prior to the Baseline visit for bleach baths.
- Washout of 2 weeks prior to the Baseline visit for phototherapy.
- 10. No history of allergy to at least two of the following classes of antibiotics: Cephalosporin, Quinolone, Tetracycline, Aminoglycosides Macrolide, Carbapenems and Lipopeptides.
- 11. Willingness to allow digital photos of arms or legs to be taken and stored.
Who cannot join
- 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 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.
- 4. Spontaneously improving or rapidly deteriorating dermatitis anywhere on the body.
- 5. Netherton's syndrome or other genetic dermatoses that result in defective epidermal barrier function.
- 6. Treatment of any type of cancer within the last 6 months other than cutaneous basal cell carcinoma.
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- 7. History of any significant internal disease (which contraindicates use of live microbiome e.g. leukemia, liver failure, cardiovascular disease).
- 8. Subjects who are known to be allergic to any of the test product(s) or any components in the test product(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure.
- 9. AIDS or AIDS related complex by medical history.
- 10. Known or suspected immune suppressive medications or diseases or any condition that in the opinion of the investigator would increase the subject's susceptibility to opportunistic infections. 11. Treatment with systemic immune modulating or anti-inflammatory biologics agents within 16 weeks of Baseline Visit.
- 12. Poorly controlled diabetes mellitus Type I or II by medical history.
- 13. Peripheral vascular disease based on medical history.
- 14. Any subject not able to meet the study attendance and telemedicine visit requirements.
- 15. Participants with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol.
- 16. 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
3 sites in 1 country.
United States3 sites
DermResearch, Inc.
Austin, Texas, 78759
North Sound Dermatology
Mill Creek, Washington, 98012
Investigate MD, LLC
Scottsdale, Arizona, 85255
About this study
Official title: A Randomized, Observer-Blinded, Within Patient Bilateral Comparison to Study the Safety and Efficacy of Daily Application for 4 Weeks of DBI-001 Gel Versus Aqueous Gel in Subjects With Atopic Dermatitis
The purpose for this study is to assess the Safety and Efficacy of Daily Application for 4 weeks of DBI-001 Gel Versus Aqueous Gel in Subjects with Atopic Dermatitis
Read the detailed description
This is a randomized, observer blinded, Aqueous Gel-controlled, within-patient, bilateral comparison trial examining the effect of daily application for 4 weeks of DBI-001 Gel vs. Aqueous Gel on the clinical Atopic Dermatitis Severity Index (ADSI) scores and the abundance of Staphylococcus aureus of comparable bilateral target sites of Atopic Dermatitis (AD), as well as signs and symptoms of local tolerability on treated sites in subjects.
Subjects meeting the inclusion/exclusion criteria and having moderate to severe AD lesions at screening and baseline/Day 1 will be enrolled into the study.
In an observer-blinded fashion, each subject will have two sites randomly assigned to have either DBI-001 Gel or Aqueous Gel applied to the designated treatment targeted sites.
After Screening, Study visits will occur at Day 1 Baseline then Days 7 (±2), 14 (±2), 21 (±2), 28 (±2), 35 (±4), and 42 (±4)
- Conditions
- Atopic Dermatitis
- Being tested
- DBI-001, Aqueous gel
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBI-001Biological
Topical application of DBI-001 gel on skin affected with atopic dermatitis.
Aqueous gelBiological
Topical application of aqueous gel on skin affected with atopic dermatitis.
| Study group | Role | What they receive |
|---|---|---|
| DBI-001 Gel | Active comparator | DBI-001 Gel: Topical application of DBI-001 gel on skin affected with atopic dermatitis.
(This study is a within-subject bilateral controlled study) Receives: Biological: DBI-001 |
| Aqueous Gel | Placebo comparator | Aqueous Gel: Topical application of aqueous gel on skin affected with atopic dermatitis.
(This study is a within-subject bilateral controlled study) Receives: Biological: Aqueous gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Change from baseline in individual signs and symptoms of Atopic Dermatitis (components of the ADSI score) at days 7, 14, 21, 28, 35, and 42 of sites treated with DBI-001 Gel or Aqueous Gel Atopic Dermatitis Severity Index: The ADSI score represents the sum of the individual severity scores of none, mild, moderate, or severe for the following component signs and symptoms: erythema, pruritus, exudation, excoriation, and lichenification. To calculate the ADSI score, the component scores are added together.
Scale for the individual components:
0=none
- mild
- moderate
- severe
Measured: 42 days of participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start6 Oct 2021
- Primary completion9 Sep 2022
- Study completion9 Sep 2022
Why it stopped: 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.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- DermBiont, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Derm Research, PLLC, Northsoundderm, Clear Dermatology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253755
- Sponsor's protocol ID
- DBI-207
- Status last verified
- Oct 2023
- First submitted
- 1 Nov 2021
- Last updated
- 8 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Observer-Blinded, Within Patient Bilateral Comparison to Study the Safety and Efficacy of Daily Application for 4 Weeks of DBI-001 Gel Versus Aqueous Gel in Subjects With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05253755
- Acronym / sponsor ID
- DBI-207
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor suspension and not due to safety or site-related matters.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- DermBiont, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Derm Research, PLLC, Northsoundderm, Clear Dermatology
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 9 Sep 2022 (actual)
- First posted
- 24 Feb 2022 (actual)
- Results
- Posted 8 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose for this study is to assess the Safety and Efficacy of Daily Application for 4 weeks of DBI-001 Gel Versus Aqueous Gel in Subjects with Atopic Dermatitis
Detailed description
This is a randomized, observer blinded, Aqueous Gel-controlled, within-patient, bilateral comparison trial examining the effect of daily application for 4 weeks of DBI-001 Gel vs. Aqueous Gel on the clinical Atopic Dermatitis Severity Index (ADSI) scores and the abundance of Staphylococcus aureus of comparable bilateral target sites of Atopic Dermatitis (AD), as well as signs and symptoms of local tolerability on treated sites in subjects.
Subjects meeting the inclusion/exclusion criteria and having moderate to severe AD lesions at screening and baseline/Day 1 will be enrolled into the study.
In an observer-blinded fashion, each subject will have two sites randomly assigned to have either DBI-001 Gel or Aqueous Gel applied to the designated treatment targeted sites.
After Screening, Study visits will occur at Day 1 Baseline then Days 7 (±2), 14 (±2), 21 (±2), 28 (±2), 35 (±4), and 42 (±4)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBI-001 Gel | Active comparator | Biological: DBI-001DBI-001 Gel: Topical application of DBI-001 gel on skin affected with atopic dermatitis. (This study is a within-subject bilateral controlled study) |
| Aqueous Gel | Placebo comparator | Biological: Aqueous gelAqueous Gel: Topical application of aqueous gel on skin affected with atopic dermatitis. (This study is a within-subject bilateral controlled study) |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (22 listed)
- 1. 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.
- 2. A signed Health Information Portability and Accountability Act (HIPAA) authorization form which permits the use and disclosure of subject's individually identifiable health information.
- 3. Male or Female Subjects of any race 12 - 65 years of age.
- 4. Physician diagnosed clinically stable AD according to the criteria of Hanifin and Rajka with symmetrical bilateral target lesions (Hanifin and Rajka 1980). Lesion on each arm or leg must have an Atopic Dermatitis Severity Index (ADSI) ≥6. The 2 sites need to be comparable anatomically symmetrical sites. It will be in the opinion of the Investigator based on subject's medical history whether the lesions are clinically stable.
- 5. Female patients of child-bearing potential must 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.
Key exclusion criteria (15 listed)
- 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 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.
- 4. Spontaneously improving or rapidly deteriorating dermatitis anywhere on the body.
- 5. Netherton's syndrome or other genetic dermatoses that result in defective epidermal barrier function.
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-001Topical application of DBI-001 gel on skin affected with atopic dermatitis. | Biological | DBI-001 Gel |
| Aqueous gelTopical application of aqueous gel on skin affected with atopic dermatitis. | Biological | Aqueous Gel |
Primary outcome
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Time frame: 42 days of participation
Change from baseline in individual signs and symptoms of Atopic Dermatitis (components of the ADSI score) at days 7, 14, 21, 28, 35, and 42 of sites treated with DBI-001 Gel or Aqueous Gel Atopic Dermatitis Severity Index: The ADSI score represents the sum of the individual severity scores of none, mild, moderate, or severe for the following component signs and symptoms: erythema, pruritus, exudation, excoriation, and lichenification. To calculate the ADSI score, the component scores are added together. Scale for the individual components: 0=none 1. mild 2. moderate 3. severe
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 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 and Aqueous gel in people with Atopic Dermatitis, run by DermBiont, Inc. at 3 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 22 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: stopped early, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 8 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline in Individual Signs and Symptoms of Atopic Dermatitis (time frame: 42 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 8 Nov 2023.