Official Title: “Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering From Atopic Dermatitis-”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Cetirizine Dry Syrup

Primary Measures

• change in the severity of pruritus

Secondary Measures

• -changes in the total pruritus score -daily main pruritus score -improvement of area with pruritus -patient global improvement -Cetirizine serum concentrations -Adverse events

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 3 Years

Maximum Age for this Clinical Trial: 14 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00257569

Study ID Number: 104913

ClinicalTrials.gov Identifier: NCT00257569

Health Authority: Japan: Ministry of Health, Labor and Welfare