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Completed

NCT Number: NCT00557284

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

1 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Montelukast

Drug

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

Drug

Oral granules or chewable tablet, PO QD (given oral daily)

Primary outcomes

  1. 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

  2. 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.

  3. 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)

  4. 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.

  5. 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).

Secondary outcomes

  1. 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)

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

1st Allergy & Clinical Research Center

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 12, 2007
Registry last updated
Apr 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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