Dermatitis, Atopic
Conditions
Keywords
Atopic, Pediatric, Dermatitis
Brief summary
To verify of cetirizine dry syrup to ketotifen dry syrup in the change in the severity of pruritus of the treatment period.
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
3 Years to 14 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in the severity of pruritus | — |
Secondary
| Measure | Time frame |
|---|---|
| -changes in the total pruritus score -daily main pruritus score -improvement of area with pruritus -patient global improvement -Cetirizine serum concentrations -Adverse events | — |
Outcome results
None listed