Status:
COMPLETED
Study Of Atopic Dermatitis In Pediatrics
Lead Sponsor:
GlaxoSmithKline
Conditions:
Dermatitis, Atopic
Eligibility:
All Genders
3-14 years
Phase:
PHASE3
Brief 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 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.
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
278 Patients enrolled
Trial Details
Trial ID
NCT00257569
Start Date
August 1 2005
Last Update
May 6 2013
Active Locations (1)
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1
GSK Investigational Site