Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens

• The change in serum and urinary inflammatory marker levels [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
• The change in GSRS validated scale for treating gastrointestinal symptoms induced by food allergens [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

• The change in serum and urinary inflammatory marker levels [ Time Frame: 9 weeks ]
• The change in GRSR validated scale for treating gastrointestinal symptoms induced by food allergens [ Time Frame: 9 weeks ]

AD is a disease found in children; the focus of the study is the mechanisms associated in children with AD induced by food allergies.

This study will be a randomized, double-blind, placebo-controlled, parallel group trial conducted in participants diagnosed with atopic dermatitis and food allergies. The study duration for participants will be approximately 9 weeks. A total of 20 participants will be recruited for the entire study. Each arm will consist of 10 participants.The study will enroll 20 children, male or female, 1 - 8 years of age with atopic dermatitis (AD) associated with food allergens, previously documented by skin or RAST test, before enrollment. Atopic dermatitis and gastrointestinal (GI) symptoms will be scored and followed throughout the study.

• Drug: Montelukast
  4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
• Drug: Placebo
  Oral granules or chewable tablet, POQD

• Experimental: 1
  Intervention: Drug: Montelukast
• Placebo Comparator: 2
  Intervention: Drug: Placebo

Inclusion Criteria:

1. Mild to moderate atopic dermatitis involving greater than or equal to 5% of body surface
2. Total severity score of 2 or greater for any 3 of the 4 signs and symptoms calculated by study doctor (erythema, papulation, or lichenification)
3. Positive skin or RAST tests by ImmunoCap to food or environmental allergens
4. GI symptoms total score of 2 by caregiver on GSRS scale revised for pediatrics

Exclusion Criteria:

1. Participants with intolerance or allergy to montelukast.
2. History of anaphylaxis requiring hospitalization.
3. No underlying renal or liver disease.
4. Participants with a diagnosis of severe asthma.
5. Participants diagnosed with primary immune deficiency.
6. Participants using sublingual immunotherapy.
7. Immunotherapy must be a maintenance dose for a minimum of 30 days.
8. If on gastrointestinal medication, 30 day stable dose before visit 1 and maintained throughout the study.