Study Of Atopic Dermatitis In Pediatrics

Dermatitis, Atopic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00257569
• Other study ID #: 104913
• Status: Completed
• Phase: Phase 3
• First received: November 21, 2005
• Last updated: May 3, 2013
• Start date: August 2005

Study information

• Verified date: May 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 14 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Cetirizine Dry Syrup

Locations

Country	Name	City	State
Spain	GSK Investigational Site	Unknown

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in the severity of pruritus
Secondary	-changes in the total pruritus score -daily main pruritus score -improvement of area with pruritus -patient global improvement -Cetirizine serum concentrations -Adverse events