Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|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|
- Change in Percentage of Body Involvement [ Time Frame: Baseline and 9 weeks ]Change in percentage of body involvement from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm for AD as measured by study investigator
- Mean Change in Investigator Global Assessment (IGA) [ Time Frame: Baseline and 9 weeks ]The mean change in IGA from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm. The IGA is a six-point measure of disease severity and is evaluated by the investigator based on the overall assessment of skin lesions: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5= very severe.
- Mean Change in PADC (Caregivers Perception of Disease Control) [ Time Frame: Baseline and 9 weeks ]Mean change in PADC from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm. Caregiver's evaluation of disease control over the previous 7 days and will consist of a four-point scale ranging from complete control (0) to uncontrolled disease (3)
- Mean Change in Pruritus [ Time Frame: Baseline and 9 weeks ]Mean change in pruritus scores from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm. Pruritus assessments ("itch") will be recorded for the previous 24 hours using a 4 point-scale, ranging from none (0) to severe (3). Scores are cumulative per week.
- Mean Change in Weekly Use of Rescue Medication for AD Flare-up - Cetirizine and/or 10% Hydrocortisone Cream [ Time Frame: Baseline and 9 weeks ]Average of weekly use of cetirizine and/or 10% hydrocortisone cream will be compared for all subjects in each arm from week 1 to week 9. Flare-up is defined as a worsening of the disease that is unacceptable to the participants and leads to second line topical steroid use and/or liquid anti-histamine use. Measurement is noted as 1 for daily use (does not correspond to multiple uses per day).
- Mean Change in Serum and Urinary Inflammatory Marker Levels [ Time Frame: Baseline and 9 weeks ]Mean change in levels from baseline to study visit 4 (week 1 compared to week 9)for interleukin 3 (IL3), tumor necrosis factor alpha (TNF alpha), nerve growth factor (NGF), and urinary leukotriene E4 (LTE4)
- Mean Change in Serum IgE Levels [ Time Frame: Baseline and 9 weeks ]Mean change in serum levels of IgE from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm.
- Mean Change in (Gastrointestinal Symptom Rating Scale) GSRS [ Time Frame: Baseline and 9 weeks ]The mean change from baseline to study visit 4 (week 1 compared to week 9) in GRGS scores (GI symptoms will be recorded on *GSRS validated scale adjusted for pediatrics (*Gastrointestinal Symptoms in Patients with Irritable Bowel Syndrome and Peptic Ulcer Disease) for all subjects in each arm.This scale measures 7 different GI symptoms (1. abdominal pain; 2. nausea and vomiting; 3. abdominal dissention; 4. decreased passage of stools; 5. increased passage of stools; 6. loose stools; 7. hard stools) with severity ranges from 0 - 3 for each point (0 being no complaint and 3 being most severe for a maximum total of 21).
|Study Start Date:||March 2008|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
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
|Placebo Comparator: 2||
Oral granules or chewable tablet, PO QD (given oral daily)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00557284
|United States, Colorado|
|1st Allergy & Clinical Research Centers|
|Centennial, Colorado, United States, 80112|
|1st Allergy & Clinical Research Centers|
|Thornton, Colorado, United States, 80229|
|Principal Investigator:||Isaac R Melamed, MD||1st Allergy & Clinical Research Center|