Study Of Cutaneous Disease Accompanied With Pruritus In Pediatrics

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Cetirizine

Criteria

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.