Study Of Atopic Dermatitis In Pediatrics

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

Summary

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

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

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Cetirizine

Criteria

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.