Allergy Asthma Immunol Res.  2016 Jul;8(4):305-311. 10.4168/aair.2016.8.4.305.

A Double-Blind, Randomized, Crossover Study to Compare the Effectiveness of Montelukast on Atopic Dermatitis in Korean Children

• Jeon YH
• Min TK
• Yang HJ
• Pyun BY

• KMID: 2165913
• DOI: http://doi.org/10.4168/aair.2016.8.4.305

Abstract

PURPOSE
Some studies report a role of leukotrienes in the pathogenesis of atopic dermatitis and suggest a rationale for the use of leukotriene receptor antagonist (LTRA) in the treatment of atopic dermatitis. This study aimed to evaluate the treatment effectiveness of montelukast in children with atopic dermatitis.
METHODS
Fifty-four children between the ages of 2 and 6 years with moderate to severe atopic dermatitis were enrolled. Group A received montelukast for 8 weeks, followed by a crossover to 8 weeks of placebo after a 2-week washout period. Group B reversed the administration according to a randomized, double-blind, placebo-controlled, crossover design. The SCORing atopic dermatitis (SCORAD) index, urinary leukotriene E4 (LTE4), and eosinophil-derived neurotoxin (EDN) were assessed at every visit.
RESULTS
Forty-three patients (21 males) completed the study. Although the SCORAD index was decreased in both groups, there was no statistically significant difference between montelukast and placebo (-3.0±11.2 vs -5.7±11.3, P=0.43). The level of urinary LTE4 was decreased after taking montelukast when compared to placebo, but there was no statistically significant difference (-65.9±556.2 vs 87.7±618.3, P=0.26). The changes in urinary EDN after taking montelukast and placebo had no significant difference (37.0±1,008.6 vs -195.8±916.7, P=0.10). When analyzing SCORAD indices, urinary LTE4, and EDN, we could not prove the effectiveness of montelukast in the atopic, non-atopic or high ECP (ECP ≥15 µg/L) subgroups.
CONCLUSIONS
There was no statistically significant difference in clinical improvement or biomarkers between montelukast and placebo treatment. Therefore, conventional treatments with skin care and infection control might be more important strategies in the treatment of atopic dermatitis.

Keyword

Atopic dermatitis; montelukast; treatment effectiveness

MeSH Terms

Biological Markers
Child*
Cross-Over Studies*
Dermatitis, Atopic*
Eosinophil-Derived Neurotoxin
Humans
Infection Control
Leukotriene E4
Leukotrienes
Receptors, Leukotriene
Skin Care
Treatment Outcome
Biological Markers
Eosinophil-Derived Neurotoxin
Leukotriene E4
Leukotrienes
Receptors, Leukotriene

Figure

• 

  Fig. 1 Study scheme. The study was a 20-week, double-blind, randomized, placebo-controlled trial with a crossover design and a 2-week washout after visit 4. The SCORAD index, and urinary leukotriene E4 (LTE4) and eosinophil-derived neurotoxin (EDN) were assessed at every visit. CBC and blood chemistry were checked at visits 2 and 4.

• 

  Fig. 2 A total of 43 patients (21 patients in group A, 22 patients in group B) out of the 54 enrolled patients completed the study. The reasons for the difference were withdrawal (n=8) and follow-up loss (n=3).

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