This study evaluates the tolerability and efficacy of a probiotic ointment compared with a comparator lotion in children with atopic dermatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
92
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
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Time frame: 28 days