An interventional study of Probiotic Ointment and Comparator product in Atopic Dermatitis, sponsored by BioGaia AB. Not yet recruiting. Open to participants aged 6 Months to 15 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by BioGaia AB · Not applicable, Interventional, and Treatment
This study evaluates the tolerability and efficacy of a probiotic ointment compared with a comparator lotion in children with atopic dermatitis.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 92 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →BioGaia AB is the lead sponsor of 20 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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 .
Exclusion Criteria Use of phototherapy for atopic dermatitis. Use of systemic within 2 weeks prior to the study. Use of 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Probiotic Ointment 2x day
Other: Probiotic Ointment
Comparator product 2x day
Other: Comparator product
Probiotic ointment
Basic lotion
Primary Endpoint
To evaluate the change in SCORAD from baseline to Day 28.
Time frame: 28 days
Secondary Endpoint
To evaluate the change in SCORAD from baseline to Day 14
Time frame: 14 days
Secondary Endpoint
To evaluate the change in local SCORAD from baseline to Day 14 and Day 28
Time frame: 14 and 28 days
Secondary Endpoint
To evaluate the change in skin barrier function (TEWL) from baseline to Day 14 and Day 28
Time frame: 14 and 28 days
Secondary Endpoint
To evaluate the change in POEM score from baseline to Day 14 and Day 28
Time frame: 14 and 28 days
Secondary endpoint
To evaluate the change in itch NRS from baseline to Day 14 and Day 28
Time frame: 14 and 28 days
Secondary Endpoint
To evaluate the use of topical corticosteroids during the study period
Time frame: 28 days
Secondary Endpoint
To explore changes in skin microbiota between baseline and Day 28
Time frame: 28 Days
Secondary Endpoint
To evaluate patient-reported tolerability and reported adverse events during the study period
Time frame: 28 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2028, 24 months later.
Of 69 industry-sponsored interventional studies with no phase under Dermatitis, Atopic, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 24. This study's planned 24 months is above that.
Counting every sponsor, half of 182 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Nov 2026, on Nov 9, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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