Study Of Atopic Dermatitis In Pediatrics

Phase 3

Completed

• Conditions: Dermatitis, Atopic

• Registration Number: NCT00257569
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-11-21
• Study First Submitted QC: 2005-11-22
• Study First Posted: 2005-11-23
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-03
• Last Update Posted: 2013-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change in the severity of pruritus

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GSK Investigational Site