Study to investigate the safety and efficacy of WAL 801 CL Dry Syrup on pruritus associated with paediatric atopic dermatitis in comparison with that of Ketotifen Fumarate Dry Syrup and to confirm the appropriateness of dosage of WAL801 Dry Syrup.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
162
Degree of pruritus
Time frame: at week 4
Degree of pruritus
Time frame: at week 2
Degree of rash
Time frame: at weeks 2 and 4
Pruritus score obtained through the itching questionnaire
Time frame: at weeks 2 and 4
Impression on pruritus of the patient or the parent
Time frame: at week 4
Occurrence of adverse events
Time frame: up to 4 weeks
Number of patients with abnormal changes from baseline in laboratory measurements (hematological tests, blood biochemical tests, and urinalysis)
Time frame: Baseline and week 4
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