Atopic Dermatitis
Conditions
Keywords
AD, Atopic Dermatitis, probiotic, Eczema
Brief summary
The goal of this study is to evaluate the efficacy of the emollient topical formulation containing Lactobacillus reuteri in improving atopic dermatitis symptoms in children.
Interventions
OTHERProbiotic Ointment
Ointment containing Lactobacillus reuteri
Sponsors
Biogaia New Sciences AB
Bioithas SL
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 12 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
History of phototherapy for the treatment of AD. 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. Underlying immune-mediated diseases requiring systemic corticosteroid therapy. Active infection in areas affected by AD requiring antibiotic, antifungal, or antiviral treatment within the one month prior to inclusion in the clinical trial. Fever at the start of treatment (axillary temperature \>37.5 °C or equivalent). Diagnosed immunodeficiency disorders. Current or past diagnosis of malignant neoplasms. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in SCORing Atopic Dermatitis (SCORAD) after 8 weeks | 8 weeks | Change in SCORing Atopic Dermatitis (SCORAD) index from baseline after 8 weeks of treatment with the topical emollient formulation containing Lactobacillus reuteri |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in SCORing Atopic Dermatitis (SCORAD) after 1 week | 1 week | Change in SCORing Atopic Dermatitis (SCORAD) index from baseline after 1 week of treatment with the topical emollient formulation containing Lactobacillus reuteri |
| Change in SCORing Atopic Dermatitis (SCORAD) after 4 weeks | 4 weeks | Change in SCORing Atopic Dermatitis (SCORAD) index from baseline after 4 weeks of treatment with the topical emollient formulation containing Lactobacillus reuteri |
| Change in POEM | 1, 4 and 8 weeks | Change in POEM score from baseline after 1, 4, and 8 weeks of treatment with the topical emollient formulation containing Lactobacillus reuteri |
| Change in PIQoL-AD | 8 weeks | Change in PIQoL-AD score from baseline after 8 weeks of treatment with the topical emollient formulation containing Lactobacillus reuteri |
Countries
Spain
Outcome results
None listed