Clinical trial NCT00557284: Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Montelukast (Singulair) in Participants Ages 1 - 8 Years Diagnosed With Atopic Dermatitis Induced by Food Allergens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis (Eczema) associated with food allergies
Lead sponsor: IMMUNOe Research Centers
Sponsor class: INDUSTRY
First posted: 2007-11-12
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 (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

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.

Primary outcomes:
measure: Change in Percentage of Body Involvement
timeFrame: Baseline and 9 weeks
measure: Mean Change in Investigator Global Assessment (IGA)
timeFrame: Baseline and 9 weeks
measure: Mean Change in PADC (Caregivers Perception of Disease Control)
timeFrame: Baseline and 9 weeks
measure: Mean Change in Pruritus
timeFrame: Baseline and 9 weeks
measure: Mean Change in Weekly Use of Rescue Medication for AD Flare-up - Cetirizine and/or 10% Hydrocortisone Cream
timeFrame: Baseline and 9 weeks
Secondary outcomes:
measure: Mean Change in Serum and Urinary Inflammatory Marker Levels
timeFrame: Baseline and 9 weeks
measure: Mean Change in Serum IgE Levels
timeFrame: Baseline and 9 weeks
measure: Mean Change in (Gastrointestinal Symptom Rating Scale) GSRS
timeFrame: Baseline and 9 weeks
Other outcomes:
Locations:
city: Centennial
country: United States
facility: 1st Allergy & Clinical Research Centers
state: Colorado
city: Thornton
country: United States
facility: 1st Allergy & Clinical Research Centers
state: Colorado
Study officials:
affiliation: 1st Allergy & Clinical Research Center
name: Isaac R Melamed, MD
role: PRINCIPAL_INVESTIGATOR
References: