Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens

Completed · Phase 4 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT00557284

Run by

1st Allergy & Clinical Research Center

People needed

20

Starts

2008-03-01

Expected to finish

2009-05-01

Last updated by the study team

2015-04-21

Who can join

Age: 1 and older, up to 8. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• 1st Allergy & Clinical Research Centers — Centennial, Colorado, United States
• 1st Allergy & Clinical Research Centers — Thornton, Colorado, United States

Full record on ClinicalTrials.gov

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