The Effectiveness of Montelukast on Atopic Dermatitis in Koreans

Pyun BokYang

Status: Completed

Conditions: Atopic Dermatitis

Treatments: Drug: Montelukast first, then placebo; Drug: Placebo first, then Montelukast

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00903357

schallergy

Details and patient eligibility

About

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).

Full 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 eosinophils and other inflammatory cells such as mast cells and macrophages. The primary action of leukotrienes includes contraction of human airway muscle, chemotaxis, and increased vascular permeability, with secondary effects of inhibiting allergen-induced early and late responses. Several in vivo and in vitro studies suggest a role for cysteinyl leukotrienes in the pathogenesis of atopic dermatitis and there is a rationale for the use of pharmacological agents to antagonize their effects in the treatment of atopic dermatitis. Levels of LTE4 measured in urine (Urinary-LTE4) may be a useful measure of whole-body cysteinyl-leukotriene production in vivo, because that LTE4 is a stable urinary metabolite of LTC4 and LTD4. Urinary-LTE4 has been measured in individuals with atopic dermatitis, but in small-scale studies, and the results are conflicting.

Enrollment: 54 patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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54 participants in 2 patient groups

Montelukast first, then placebo

Experimental group

Description:

The group received active medication (montelukast 4 mg or 5mg once daily) for 8 weeks followed by a crossover to 8 weeks of placebo after 2-weeks washout period.

Treatment:

Drug: Placebo first, then Montelukast

Drug: Montelukast first, then placebo

Placebo first, then Montelukast

Experimental group

Description:

The group received placebo medication (ascorbic acid) for 8 weeks followed by a crossover to 8 weeks of active medication (montelukast 4 mg or 5mg once daily) after 2-weeks washout period.

Treatment:

Drug: Placebo first, then Montelukast

Drug: Montelukast first, then placebo