Efficacy and Tolerability of a Probiotic Ointment

NCT07701447 — Not applicable, Not yet recruiting, 92 participants, BioGaia AB

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Registry	NCT07701447
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	92 (Estimated)
Sponsor	BioGaia AB (Industry); collaborators: Zurko Research
Conditions	Atopic Dermatitis
Interventions	Probiotic Ointment, Comparator product (Other)
Dates	start 2026-08-01 (estimated), primary completion 2028-11-01 (estimated), completion 2028-11-01 (estimated), first posted 2026-07-14, last updated 2026-07-15

-Summary

This study evaluates the tolerability and efficacy of a probiotic ointment compared with a comparator lotion in children with atopic dermatitis.

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+Arms and interventions

Arm	Type	Interventions	Description
Probiotic Ointment	Experimental	Other: Probiotic Ointment	Probiotic Ointment 2x day
Comparator Product	Experimental	Other: Comparator product	Comparator product 2x day

Probiotic Ointment (Other): Probiotic ointment
Comparator product (Other): Basic lotion

+Outcome measures

Primary outcomes

Primary Endpoint [28 days]: To evaluate the change in SCORAD from baseline to Day 28.

Secondary outcomes

Secondary Endpoint [14 days]: To evaluate the change in SCORAD from baseline to Day 14
Secondary Endpoint [14 and 28 days]: To evaluate the change in local SCORAD from baseline to Day 14 and Day 28
Secondary Endpoint [14 and 28 days]: To evaluate the change in skin barrier function (TEWL) from baseline to Day 14 and Day 28
Secondary Endpoint [14 and 28 days]: To evaluate the change in POEM score from baseline to Day 14 and Day 28
Secondary endpoint [14 and 28 days]: To evaluate the change in itch NRS from baseline to Day 14 and Day 28
Secondary Endpoint [28 days]: To evaluate the use of topical corticosteroids during the study period
Secondary Endpoint [28 Days]: To explore changes in skin microbiota between baseline and Day 28
Secondary Endpoint [28 days]: To evaluate patient-reported tolerability and reported adverse events during the study period

+Eligibility

Sex: All, ages: 6 Months to 15 Years

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.