N/A
Completed N=54
The Effectiveness of Montelukast on Atopic Dermatitis in Koreans
Source: ClinicalTrials.gov NCT00903357 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcomePrimary: Changes in SCORAD Index — -3.0; -5.7 units on a scale
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 role of modulating the atopic dermatitis measured by urinary Leukotriene 4 (LTE4) and Eosinophil protein X(EDN).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in SCORAD Index |
-3.0; -5.7 | — |
| PRIMARY Changes in Urinary LTE4 |
-65.9; 87.7 | — |
| PRIMARY Changes in Urinary EDN |
37.0; -195.8 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00903357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.