Study Of Cutaneous Disease Accompanied With Pruritus In Pediatrics

Phase 3

Completed

Brief Summary: To assess the safety of long-term use of cetirizine dry syrup in children with various type of cutaneous disease accompanied on pruritus.

Recruitment & Eligibility

Inclusion Criteria

Chronic urticaria
Eczema & dermatitis group
Atopic dermatitis
Prurigo group: Acute prurigo, Prurigo subacuta, Chronic prurigo
Pruritus cutaneous: Systemic pruritus cutaneous, Topical pruritus cutaneous
Giving informed consent
Children who have 2 grades or more pruritus score when assessed by the investigator or sub-investigator with the criteria for the diurnal or nocturnal pruritus score in the patient diary.
Children with a pruritus severity of "2.Mild" or severer on the first day of the treatment period.

Exclusion criteria:

have a history of drug hypersensitivity
are pregnant, lactating or possibly pregnant female children.
have asthma that requires the treatment with corticosteroid.
cannot avoid the use of external steroid classified into "strong", "strongest" or "very strong".
have pruritus only on face and head.
have inappropriate complication of dermal disorder that may influence on the evaluation of the study drug.
are undergoing specific desensitization therapy or immunomodulation therapy or phototherapy.

Primary Outcome Measures

Name	Time	Method
To assess the safety

Secondary Outcome Measures

Name	Time	Method
-severity of pruritus -total pruritus score -daily main prurutus score -Severity of eruption -Patient global Improvement rating -Body temperature -Adverse events -Cetirizine serum concentrations