Study Of Cutaneous Disease Accompanied With Pruritus In Pediatrics

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Pruritus

Treatments

Drug: Cetirizine Dry Syrup

Study type

Interventional

Funder types

Industry

Identifiers

104915

Details and patient eligibility

About

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

Sex

All

Ages

2 to 14 years old

Volunteers

No Healthy Volunteers

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.