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Completed

NCT Number: NCT00257569

Study Of Atopic Dermatitis In Pediatrics

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

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Key information

Conditions

Dermatitis, Atopic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

3 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cetirizine Dry Syrup

Drug

Primary outcomes

  1. change in the severity of pruritus

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering From Atopic Dermatitis-

Important dates

Study start
2005
First posted
Nov 23, 2005
Registry last updated
May 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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