Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis (Eczema) associated with food allergies
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 20
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Montelukast arm 2: None

Interventions: intervention 1: Montelukast intervention 2: Placebo
Intervention descriptions: intervention 1: 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 intervention 2: Oral granules or chewable tablet, PO QD (given oral daily)

Protocol document: