Study Of Atopic Dermatitis In Pediatrics

Last updated: May 3, 2013
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

3

Condition

Allergy

Rash

Atopic Dermatitis

Treatment

N/A

Clinical Study ID

NCT00257569
104913
  • Ages 3-14
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 faceand head.

  • Children with a pruritus severity of 2.

  • Mild or severe on the fist day of the treatment period.

Exclusion

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 verystrong

  • have eczematous otitis externa with perforation in the eardrum

  • have dermal ulcer, or profound heat burn or frostbite of the severity higher than thegrade 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 theevaluation of the study drug

  • are undergoing specific desensitization therapy or immunomodulation therapy orphototherapy.

Study Design

Total Participants: 278
Study Start date:
August 01, 2005
Estimated Completion Date:

Connect with a study center

  • GSK Investigational Site

    Unknown,
    Spain

    Site Not Available

  • GSK Investigational Site

    ,

    Site Not Available

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