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 2026-07-15.
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.
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.
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.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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