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Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens

NCT00557284·2 sites·ClinicalTrials.gov

What this study is about

Take this into the appointment.

Saves the questions and what to expect into your notes, next to the visit they belong to.

Keep this study

Lead

1st Allergy & Clinical Research Center

Age

1–8

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible if

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 (radioallergosorbent) RAST tests by ImmunoCap to food or environmental allergens
4. GI symptoms total score of 2 by caregiver on GSRS scale revised for pediatrics

You may not be if

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.

The record

StatusCompleted

PhasePhase 4

Taking part20

StartedMar 2008

UpdatedApr 21, 2015

Conditions

Atopic Dermatitis

Where2

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