Study Of Atopic Dermatitis In Pediatrics

This study has been completed. 

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

Condition: Atopic Dermatitis
Intervention: Drug: Cetirizine Dry Syrup
Phase: Phase III

Study Type:  Interventional
Study Design:  Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:  Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering From Atopic Dermatitis-

Eligibility
Ages Eligible for Study:  3 Years to 14 Years
Genders Eligible for Study:  Both

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.

Sponsors and Collaborators:  GlaxoSmithKline UCB
Information provided by:  GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00257569

NCT ID †  NCT00257569
Organization ID 104913
Secondary IDs †† RPCE04E1102/A00387
Study Sponsor † GlaxoSmithKline
Collaborators †† UCB
Investigators †
Study Director:    GSK Clinical Trials, MD   GlaxoSmithKline  
Information Provided By GlaxoSmithKline
Verification Date July 2007
First Received Date † November 21, 2005

†  Required WHO trial registration data element.
††  WHO trial registration data element that is required only if it exists.

ClinicalTrials.gov Identifie