Status:
COMPLETED
The Effectiveness of Montelukast on Atopic Dermatitis in Koreans
Lead Sponsor:
Pyun BokYang
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
2-6 years
Phase:
NA
Brief Summary
The purpose of this study is to assess the clinical effectiveness of Montelukast in children (2\~6 years old) with atopic dermatitis and identify the pathophysiologic background of Montelukast on the ...
Detailed Description
Leukotriene B4 (LTB4) and the cysteinyl-leukotrienes LTC4, LTD4 and LTE4 are potent proinflammatory mediators derived from arachidonic acid through the 5- lipoxygenase pathway. They are secreted from ...
Eligibility Criteria
Inclusion
- The ages of 2 to 6 years old, 54 children with moderate to severe atopic dermatitis diagnosed by the criteria of Haniffin and Rajka were included in the study.
- Volunteer children with moderate to severe atopic dermatitis were recruited from the Pediatric Allergy and respiratory Center of the SoonChunHyang University Hospital (Seoul, Korea). At the time of recruitment, written consent was obtained. The ethical committee at the SoonChunHyang University Hospital approved the trial.
- Volunteers who agreed by their parents.
- The severity of their disease was assessed by modified SCORAD index.
Exclusion
- Too severe atopic dermatitis defined as the sum of scores is 80 and above by SCORAD index.
- A history of liver disease; allergy to montelukast or cross-reacting medication; use of phenobarbital, phenytoin or rifampicin.
- Patients on systemic steroids, immune-suppression or Korean herbal medicine during the previous 6 weeks.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00903357
Start Date
August 1 2009
End Date
April 1 2011
Last Update
December 14 2015
Active Locations (1)
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1
Pediatric Allergy & Respiratory Center, Department of Pediatrics, Soonchunhyang University Hospital
Seoul, South Korea, 140-743