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Study Of Atopic Dermatitis In Pediatrics

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ClinicalTrials.gov Identifier: NCT00257569
Recruitment Status : Completed
First Posted : November 23, 2005
Last Update Posted : May 6, 2013
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: Cetirizine Dry Syrup Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering From Atopic Dermatitis-
Study Start Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Itching
U.S. FDA Resources

Primary Outcome Measures :
  1. change in the severity of pruritus

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

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00257569

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00257569     History of Changes
Other Study ID Numbers: 104913
First Posted: November 23, 2005    Key Record Dates
Last Update Posted: May 6, 2013
Last Verified: May 2013

Keywords provided by GlaxoSmithKline:

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs