The safety and efficacy of WAL 801 CL (epinastine hydrochloride) Dry Syrup in the treatment of atopic dermatitis in children was evaluated and plasma drug concentrations were measured.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Overall incidence of adverse events
Time frame: up to 12 weeks
Occurrence of abnormal changes in laboratory measurements (haematological tests, blood biochemical tests, and urinalysis)
Time frame: Baseline, weeks 4, 8 and 12
Degree of pruritus
Time frame: at weeks 4, 8 and 12
Degree of rash
Time frame: at weeks 4, 8 and 12
Pruritus score obtained through the itching questionnaire
Time frame: at weeks 4, 8 and 12
Impression on pruritus of the patient or the parent
Time frame: week 12
Plasma concentration of epinastine hydrochloride
Time frame: pre-dose and 6, 12, 18, 24, 30, 36 hours post-dose
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