A Clinical Trial Evaluating a Probiotic Emollient for the Treatment of Pediatric Atopic Dermatitis

Prior treatment

• Previous treatment with biologic agents or JAK inhibitors for AD.
• Use of systemic corticosteroids within one month prior to inclusion in the clinical trial.
• Use of topical corticosteroids within one month prior to inclusion in the clinical trial.
• Use of conventional systemic immunosuppressants for AD (e.g., azathioprine, methotrexate, or cyclosporine) within three months prior to inclusion in the clinical trial.
• Use of oral or topical probiotics within two months prior to inclusion in the clinical trial.
• Use of topical or systemic antibiotics within one month prior to inclusion in the clinical trial.
• Known hypersensitivity to the investigational product or any of its components.
• Active infection in areas affected by AD requiring antibiotic, antifungal, or antiviral treatment within the one month prior to inclusion in the clinical trial.
• Any concurrent dermatologic or medical condition that, in the investigator's opinion, could interfere with the subject's response to treatment or require continuous use of topical corticosteroids.
• Participation in other clinical research studies involving investigational products within one month prior to inclusion in the clinical trial.

Other illness

• History of phototherapy for the treatment of AD.
• Underlying immune-mediated diseases requiring systemic corticosteroid therapy.
• Diagnosed immunodeficiency disorders.
• Current or past diagnosis of malignant neoplasms.

Other

• Fever at the start of treatment (axillary temperature \>37.5 °C or equivalent).

• Pediatric patients of both sexes, aged between 6 months and 12 years, with a confirmed diagnosis of AD based on Hanifin and Rajka criteria (ANNEX VIII).
• SCORAD index between 20 and 50, inclusive.
• Signed informed consent by parents or legal guardians.