Atopic DermatitisNCT04771910
Study of the Skin Microbiome and the Potential of a Topical Probiotic Cream for Atopic Dermatitis
A study testing Topical cream with live probiotic bacteria in people with Atopic Dermatitis, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
The skin microbiome of atopic dermatitis patients and healthy volunteers will be studies by collecting and analysing skin swabs on different timepoint. Additional, effort will be made to isolate and characterize Lactobacillus spp. and other beneficial micro-organisms on the skin. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Topical cream with live probiotic bacteria
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2021to 1 Jan 2022
- Phase
- Interventional
- 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 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with atopic dermatitis and healthy volunteers
Who cannot join
- no use of topical antibiotics and/or corticosteroids within 2 weeks before the start
- no use of oral antibiotics within 1 month before the start
- no immunodeficiency disease
- no use of topical antibiotics and/or corticosteroids within 2 weeks before the start
- no use of oral antibiotics within 1 month before the start
- no immunodeficiency disease
- no history of atopic dermatitis or other inflammatory skin disorders
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Antwerp
Edegem, Antwerp, 2650
Margo Hagendorens, Prof, +3238213000, margo.hagendorens@uantwerpen.be
Lize Delanghe, Msc, +3232653240, lize.delanghe@uantwerpen.be
About this study
The skin microbiome of atopic dermatitis patients and healthy volunteers will be studies by collecting and analysing skin swabs on different timepoint. Additional, effort will be made to isolate and characterize Lactobacillus spp. and other beneficial micro-organisms on the skin. Second aim of this study is to evaluate a topical probiotic cream in atopic dermatitis treatment. A double-blind placebo-controlled intervention study will be performed in parallel with the skin microbiome analysis. Both clinical effect on the symptoms of atopic dermatitis and effect on the skin microbiome and survival of beneficial bacteria on the skin will be evaluated.
Read the detailed description
Probiotics are live micro-organisms which when administered in adequate amounts can exert a health benefit on the host. This health-promoting effects have been extensively studied in the gastrointestinal niche but it becomes more and more clear that other niches are also interesting for the potential of probiotics. Recent breakthroughs in 'next generation sequencing' (NGS) technologies are making it now possible to map the microbiota after DNA extraction, which is very interesting for bacteria that are not or difficult to cultivate. The research into the microbiota of the skin with such new NGS technologies shows that there is also an equilibrium in the skin composition of the microbiota and that there is a disturbance of the skin microbiota in atopic dermatitis (AD). The etiology of AD is complex, with the manifestation of the disease being influenced by various genetic and immune mechanisms acting in concert with environmental factors. A reduction in the skin microbial diversity is often observed and flares are characterized by an abundance of skin pathobionts such as Staphylococcus aureus. Therefore, topical probiotic strains could have a positive effect on the skin microbiome and function by inhibiting pathogens, restoring the skin microbiome and/or barrier function and executing anti-inflammatory effects on the skin cells. The main objectives of this study are to analyse the skin microbiome in healthy volunteers and patients AD to obtain in depth data of the composition of the skin microbiome and identify possible biomarkers for AD. In parallel, a double-blind placebo-controlled study with topically applied live lactobacilli will be performed to give more insights in the working mechanisms of lactobacilli on AD skin. More specifically to evaluate the effect of the 'live' Lactobacillus species as 'active ingredient' in relation to acne symptoms and skin microbiome modulation.
- Conditions
- Atopic Dermatitis
- Being tested
- Topical cream with live probiotic bacteria, Placebo cream
- Keywords
- Skin microbiome, Probiotics, Lactobacillus spp.
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical cream with live probiotic bacteriaOther
Also called ACN cream (YUN)
Application of the probiotic cream once a day, for approximately 8 weeks on one side of the body (elbow or knee cavity; decided by doctor in advance, same as placebo cream). Assessment before product use (T0), after 4 and 8 weeks of product use (T4w and T8w, respectively) and after 4 weeks without product use (T12w).
Placebo creamOther
Application of the placebo cream (same formulation as probiotic cream except live probiotic bacteria) once a day, for approximately 8 weeks on one side of the body (elbow or knee cavity; decided by doctor in advance, same as probiotic cream). Assessment before product use (T0), after 4 and 8 weeks of product use (T4w and T8w, respectively) and after 4 weeks without product use (T12w).
| Study group | Role | What they receive |
|---|---|---|
| Topical cream with live probiotic bacteria (YUN) | Experimental | Patients with atopic dermatitis using topical cream with live probiotic bacteria Receives: Other: Topical cream with live probiotic bacteria |
| Placebo cream (YUN) | Placebo comparator | Patients with atopic dermatitis using placebo cream (same formulation as probiotic cream except live probiotic bacteria) Receives: Other: Placebo cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in skin microbiome composition
Extraction of microbial DNA out of skin swabs. Analysis of differences in bacterial communities colonizing the skin between healthy individuals and AD patients measured via Next Generation Sequencing techniques and qPCR assays.
Measured: AD patients: skin swabs at baseline,4 and 8 weeks of product use and 4 weeks without product use (total 12 weeks). Healthy volunteers: skin swab at baseline and after 12 weeks (no product use)..
Change from baseline in AD severity scoring based on Eczema Area and Severity Index
Evaluation of atopic dermatitis symptoms via a scoring system based on Eczema Area and Severity Index (EASI). The EASI will be adjusted to the limited area of elbow or knee cavities.
Measured: AD patients: skin swabs at baseline,4 and 8 weeks of product use and 4 weeks without product use (total 12 weeks). Healthy volunteers: NA
Change from baseline in itching via Visual Analogue Scale
The effect of the treatment of itching of the skin caused by atopic dermatitis lesions will be evaluated using Visual Analogue Scale (VAS).
Measured: AD patients: skin swabs at baseline,4 and 8 weeks of product use and 4 weeks without product use (total 12 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Jan 2021
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2022 (estimated)
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.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All AD patients will receive both treatments (verum and placebo). Verum cream will be applied on one side of the body (elbow or knee cavities), the placebo cream on the other side.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- YUN NV
- Responsible party
- Principal investigator, ethisch.comite@uza.be, Universiteit Antwerpen
- Investigators
- Sarah Lebeer, Prof, Principal investigator, Universiteit AntwerpenMargo Hagendorens, Prof, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771910
- Sponsor's protocol ID
- B3002020000099
- Status last verified
- Apr 2021
- First submitted
- 14 Aug 2020
- Last updated
- 28 Apr 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 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Skin Microbiome and the Potential of a Topical Probiotic Cream for Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT04771910
- Acronym / sponsor ID
- B3002020000099
- Conditions
- Atopic Dermatitis
- Keywords
- Skin microbiome, Probiotics, Lactobacillus spp.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- YUN NV
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 25 Feb 2021 (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.
The skin microbiome of atopic dermatitis patients and healthy volunteers will be studies by collecting and analysing skin swabs on different timepoint. Additional, effort will be made to isolate and characterize Lactobacillus spp. and other beneficial micro-organisms on the skin. Second aim of this study is to evaluate a topical probiotic cream in atopic dermatitis treatment. A double-blind placebo-controlled intervention study will be performed in parallel with the skin microbiome analysis. Both clinical effect on the symptoms of atopic dermatitis and effect on the skin microbiome and survival of beneficial bacteria on the skin will be evaluated.
Detailed description
Probiotics are live micro-organisms which when administered in adequate amounts can exert a health benefit on the host. This health-promoting effects have been extensively studied in the gastrointestinal niche but it becomes more and more clear that other niches are also interesting for the potential of probiotics. Recent breakthroughs in 'next generation sequencing' (NGS) technologies are making it now possible to map the microbiota after DNA extraction, which is very interesting for bacteria that are not or difficult to cultivate. The research into the microbiota of the skin with such new NGS technologies shows that there is also an equilibrium in the skin composition of the microbiota and that there is a disturbance of the skin microbiota in atopic dermatitis (AD). The etiology of AD is complex, with the manifestation of the disease being influenced by various genetic and immune mechanisms acting in concert with environmental factors. A reduction in the skin microbial diversity is often observed and flares are characterized by an abundance of skin pathobionts such as Staphylococcus aureus. Therefore, topical probiotic strains could have a positive effect on the skin microbiome and function by inhibiting pathogens, restoring the skin microbiome and/or barrier function and executing anti-inflammatory effects on the skin cells. The main objectives of this study are to analyse the skin microbiome in healthy volunteers and patients AD to obtain in depth data of the composition of the skin microbiome and identify possible biomarkers for AD. In parallel, a double-blind placebo-controlled study with topically applied live lactobacilli will be performed to give more insights in the working mechanisms of lactobacilli on AD skin. More specifically to evaluate the effect of the 'live' Lactobacillus species as 'active ingredient' in relation to acne symptoms and skin microbiome modulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All AD patients will receive both treatments (verum and placebo). Verum cream will be applied on one side of the body (elbow or knee cavities), the placebo cream on the other side.
| Arm | Type | Receives |
|---|---|---|
| Topical cream with live probiotic bacteria (YUN) | Experimental | Other: Topical cream with live probiotic bacteriaPatients with atopic dermatitis using topical cream with live probiotic bacteria |
| Placebo cream (YUN) | Placebo comparator | Other: Placebo creamPatients with atopic dermatitis using placebo cream (same formulation as probiotic cream except live probiotic bacteria) |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with atopic dermatitis and healthy volunteers
Key exclusion criteria (7 listed)
- no use of topical antibiotics and/or corticosteroids within 2 weeks before the start
- no use of oral antibiotics within 1 month before the start
- no immunodeficiency disease
- no use of topical antibiotics and/or corticosteroids within 2 weeks before the start
- no use of oral antibiotics within 1 month before the start
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 |
|---|---|---|
| Topical cream with live probiotic bacteriaAlso: ACN cream (YUN)Application of the probiotic cream once a day, for approximately 8 weeks on one side of the body (elbow or knee cavity; decided by doctor in advance, same as placebo cream). Assessment before product use (T0), after 4 and 8 weeks of product use (T4w and T8w, respectively) and after 4 weeks without product use (T12w). | Other | Topical cream with live probiotic bacteria (YUN) |
| Placebo creamApplication of the placebo cream (same formulation as probiotic cream except live probiotic bacteria) once a day, for approximately 8 weeks on one side of the body (elbow or knee cavity; decided by doctor in advance, same as probiotic cream). Assessment before product use (T0), after 4 and 8 weeks of product use (T4w and T8w, respectively) and after 4 weeks without product use (T12w). | Other | Placebo cream (YUN) |
Primary outcome
Change from baseline in skin microbiome composition
Time frame: AD patients: skin swabs at baseline,4 and 8 weeks of product use and 4 weeks without product use (total 12 weeks). Healthy volunteers: skin swab at baseline and after 12 weeks (no product use)..
Extraction of microbial DNA out of skin swabs. Analysis of differences in bacterial communities colonizing the skin between healthy individuals and AD patients measured via Next Generation Sequencing techniques and qPCR assays.
Change from baseline in AD severity scoring based on Eczema Area and Severity Index
Time frame: AD patients: skin swabs at baseline,4 and 8 weeks of product use and 4 weeks without product use (total 12 weeks). Healthy volunteers: NA
Evaluation of atopic dermatitis symptoms via a scoring system based on Eczema Area and Severity Index (EASI). The EASI will be adjusted to the limited area of elbow or knee cavities.
Change from baseline in itching via Visual Analogue Scale
Time frame: AD patients: skin swabs at baseline,4 and 8 weeks of product use and 4 weeks without product use (total 12 weeks).
The effect of the treatment of itching of the skin caused by atopic dermatitis lesions will be evaluated using Visual Analogue Scale (VAS).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 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.
Sarah Lebeer, Prof principal investigator
Universiteit Antwerpen
Margo Hagendorens, Prof principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical cream with live probiotic bacteria in people with Atopic Dermatitis, run by University Hospital, Antwerp at 1 site in Belgium.
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 1 inclusion and 7 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 28 Apr 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 Belgium. 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.
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?
Contact Sarah Lebeer, Prof (+3232653285, sarah.lebeer@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in skin microbiome composition (time frame: AD patients: skin swabs at baseline,4 and 8 weeks of product use and 4 weeks without product use (total 12 weeks). Healthy volunteers: skin swab at baseline and after 12 weeks (no product use)..). The study lists 3 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 28 Apr 2021.