Effects of an Emollient Containing Postbiotic Saccharomyces and Lactobacillus on Pediatric Atopic Dermatitis

Prior treatment

• Children who have received topical medication within 14 days prior to enrollment, including calcineurin inhibitors (e.g., topical tacrolimus or pimecrolimus), corticosteroid formulations, or topical antihistamines.
• Children who have received non-steroidal immunosuppressants (e.g., cyclosporine, methotrexate) or phototherapy, systemic corticosteroids, or systemic antihistamines within 4 weeks prior to enrollment.
• Any condition or previous/concurrent treatment that makes the subject ineligible for this study.

Other illness

• Children with acute exacerbation characterized by erosion, exudation, or secondary infection.
• Presence of open skin infections (bacterial, viral, or fungal) at the application site.
• Children with severe immune system disorders (such as lymphoma, AIDS, Wiskott-Aldrich syndrome) or a history of malignant tumors.
• Children with severe heart, liver, or kidney diseases.
• Children with other skin diseases in the treatment area besides atopic dermatitis.
• Known allergy to hydrocortisone butyrate cream or the test product.

Other

• Do not meet the diagnostic criteria established by Williams.
• Children currently participating in other clinical studies or having participated within the last 3 months.
• Poor compliance of the subject, known inability to attend visits on time, or unwillingness to comply with the study protocol during the study period.

• Participants must meet the diagnostic criteria established by Williams.
• Moderate atopic dermatitis is defined by an Eczema Area and Severity Index (EASI) score of 7.1 to 21.0, and an Investigator's Global Assessment (IGA) score of 3.
• Age range is 0 to 6 years, with no gender restrictions.
• Guardians of the participants must be willing to apply the test product to the participants as directed by the physician throughout the study period.
• Participants should not have received topical medication within 14 days prior to enrollment, including calcineurin inhibitors (e.g., topical tacrolimus or pimecrolimus), corticosteroid formulations, or topical antihistamines.
• Within 4 weeks prior to enrollment, participants should not have received non-steroidal immunosuppressants (e.g., cyclosporine, methotrexate) or phototherapy, nor should they have used systemic corticosteroids or systemic antihistamines.
• Participants are not allowed to use other similar products during the entire study period.
• Prior to the commencement of any study-specific examination or procedural step, participants must sign an informed consent form. For infants and young children aged 0 to 6 years, the guardians must sign an informed consent waiver on behalf of the child and also sign a parental version of the informed consent form.