Study Of Atopic Dermatitis In Pediatrics

Phase 3

Completed

Brief Summary: To verify of cetirizine dry syrup to ketotifen dry syrup in the change in the severity of pruritus of the treatment period.

Recruitment & Eligibility

Inclusion Criteria

Children diagnosed as atopic dermatitis
Giving informed consent
Children who have 2 grades or more pruritus score.
Children who require the treatment with external steroid preparation other than face and head.
Children with a pruritus severity of 2.
Mild or severe on the fist day of the treatment period.

Exclusion criteria:

have spastic disease such as epilepsy
have a history of drug hypersensitivity
are lactating or possibly pregnant female Children
have a skin infection, or with zooparasite such as scabies and pediculosis
cannot avoid the use of external steroid classified into strong, strongest or very strong
have eczematous otitis externa with perforation in the eardrum
have dermal ulcer, or profound heat burn or frostbite of the severity higher than the grade 2
have asthma that requires the treatment with corticosteroid
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
change in the severity of pruritus

Secondary Outcome Measures

Name	Time	Method
-changes in the total pruritus score -daily main pruritus score -improvement of area with pruritus -patient global improvement -Cetirizine serum concentrations -Adverse events