Pruritus
Conditions
Keywords
cetirizine, various type of cutaneous disease accompanied with Pruritus, pediatrics
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.
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 14 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety | — |
Secondary
| Measure | Time frame |
|---|---|
| -severity of pruritus -total pruritus score -daily main prurutus score -Severity of eruption -Patient global Improvement rating -Body temperature -Adverse events -Cetirizine serum concentrations | — |
Outcome results
None listed