Atopic DermatitisNCT07701447
Efficacy and Tolerability of a Probiotic Ointment
A study testing Probiotic Ointment and Comparator product in people with Atopic Dermatitis, run by BioGaia AB.
Trial summary
This study evaluates the tolerability and efficacy of a probiotic ointment compared with a comparator lotion in children with atopic dermatitis. Read more about this study
- Who is it for?
- Ages 6 months to 15 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Probiotic Ointment and Comparator product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 15 years
- All sexes
- No healthy volunteers
- Child
Inclusion Criteria Male and female pediatric patients aged 0.5 years to 15 years with Atopic Dermatitis.
SCORAD Index at D0 = 15 to 50, inclusive. In goodgeneral health as reported by the parent(s)/legal representative(s). Available for the full duration of the study and willing to comply with procedures.
Subjects whose parents or legal representative are willing to sign the informed consent.
Exclusion Criteria Use of phototherapy for atopic dermatitis. Use of systemic corticosteroids within 2 weeks prior to the study. Use of Immunosuppressive or cytostatic drugs within 1 months prior to the study.
Use of antibiotics (topical and systemic) within 15 days prior to the start of the study.
Subjects who are treated with vitamin A-derived compounds or other topical medications for acne in the experimental area during the 30 days prior to the start of the study.
History of sensitivity to the study products, or its components. History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).
Subjects with active infection in atopic dermatitis areas requiring antibiotics, antifungals, or antiviral agents within 7 days before baseline participation in any study that would interfere with the current study.
Fever (temperature> 37.5 °C axillary or equivalent) during 48 hours prior the start of the study.
Pathologies associated with immunodeficiency or cancer processes. Any concurrent dermatologic or medical conditions that may interfere with the investigators ability to assess the subject's response to the study drug or require the continued use of topical corticosteroids.
Subjects who have received the schedule MMR vaccination during the study period or have received the last dose within three weeks prior the start of the study.
Subjects who participates in any study that would interfere with the current study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study evaluates the tolerability and efficacy of a probiotic ointment compared with a comparator lotion in children with atopic dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- Probiotic Ointment, Comparator product
- Keywords
- Atopic Dermatitis, Probiotic, Microbiome, Ointment
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic OintmentOther
Probiotic ointment
Comparator productOther
Basic lotion
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Ointment | Experimental | Probiotic Ointment 2x day Receives: Other: Probiotic Ointment |
| Comparator Product | Experimental | Comparator product 2x day Receives: Other: Comparator product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
To evaluate the change in SCORAD from baseline to Day 28.
Measured: 28 days
Secondary outcomes (8)
Secondary Endpoint
To evaluate the change in SCORAD from baseline to Day 14
Measured: 14 days
Secondary Endpoint
To evaluate the change in local SCORAD from baseline to Day 14 and Day 28
Measured: 14 and 28 days
Secondary Endpoint
To evaluate the change in skin barrier function (TEWL) from baseline to Day 14 and Day 28
Measured: 14 and 28 days
Secondary Endpoint
To evaluate the change in POEM score from baseline to Day 14 and Day 28
Measured: 14 and 28 days
Secondary endpoint
To evaluate the change in itch NRS from baseline to Day 14 and Day 28
Measured: 14 and 28 days
Secondary Endpoint
To evaluate the use of topical corticosteroids during the study period
Measured: 28 days
Secondary Endpoint
To explore changes in skin microbiota between baseline and Day 28
Measured: 28 Days
Secondary Endpoint
To evaluate patient-reported tolerability and reported adverse events during the study period
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (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.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioGaia AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zurko Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701447
- Sponsor's protocol ID
- BNS_RD_004
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of a Probiotic Ointment
- ClinicalTrials.gov ID
- NCT07701447
- Acronym / sponsor ID
- BNS_RD_004
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Probiotic, Microbiome, Ointment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- BioGaia ABIndustry (pharma, biotech, devices)
- Collaborators
- Zurko Research
- Study start
- Aug 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 14 Jul 2026 (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 study evaluates the tolerability and efficacy of a probiotic ointment compared with a comparator lotion in children with atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Ointment | Experimental | Other: Probiotic OintmentProbiotic Ointment 2x day |
| Comparator Product | Experimental | Other: Comparator productComparator product 2x day |
Who may qualify
- Ages
- 6 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Probiotic OintmentProbiotic ointment | Other | Probiotic Ointment |
| Comparator productBasic lotion | Other | Comparator Product |
Primary outcome
Primary Endpoint
Time frame: 28 days
To evaluate the change in SCORAD from baseline to Day 28.
8 secondary outcomes
Secondary Endpoint
Time frame: 14 days
Secondary Endpoint
Time frame: 14 and 28 days
Secondary Endpoint
Time frame: 14 and 28 days
Secondary Endpoint
Time frame: 14 and 28 days
Secondary endpoint
Time frame: 14 and 28 days
Secondary Endpoint
Time frame: 28 days
Secondary Endpoint
Time frame: 28 Days
Secondary Endpoint
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Ointment and Comparator product in people with Atopic Dermatitis, run by BioGaia AB.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sofia Nordh, PhD (+46 (0)8 555 293 00, son@biogaianewsciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: 28 days). 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 15 Jul 2026.