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Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens
This study is currently recruiting participants.
Verified by 1st Allergy & Clinical Research Center, November 2007
First Received: November 9, 2007   No Changes Posted
Sponsor: 1st Allergy & Clinical Research Center
Collaborator: Merck
Information provided by: 1st Allergy & Clinical Research Center
ClinicalTrials.gov Identifier: NCT00557284
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis
 Drug: Montelukast
Drug: Placebo
 Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parellel Group Study to Evaluate the Efficacy of Montelukast (Singulair) in Participants Ages 1 - 8 Years Diagnosed With Atopic Dermatitis Induced by Food Allergens

Resource links provided by NLM:

MedlinePlus related topics: Allergy Food Allergy
Drug Information available for: Montelukast sodium Montelukast
U.S. FDA Resources

Further study details as provided by 1st Allergy & Clinical Research Center:

Primary Outcome Measures:
  • The change in validated skin assessment scores (EASI) in treating symptoms of atopic dermatitis associated with food allergens [ Time Frame: 9 weeks ]

Secondary Outcome Measures:
  • The change in serum and urinary inflammatory marker levels [ Time Frame: 9 weeks ]
  • The change in GRSR validated scale for treating gastrointestinal symptoms induced by food allergens [ Time Frame: 9 weeks ]

Estimated Enrollment: 20
Study Start Date: November 2007
Estimated Study Completion Date: March 2008
Arms Assigned Interventions
1: Experimental Drug: Montelukast
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
2: Placebo Comparator Drug: Placebo
Oral granules or chewable tablet, POQD

  Eligibility

Ages Eligible for Study:   1 Year to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Mild to moderate atopic dermatitis involving 10-25% of body surface
  2. Total severity score of 4 or greater for any 3 of the 4 signs and symptoms calculated by study doctor (erythema, papulation, or lichenification)
  3. Positive skin or RAST tests by ImmunoCap to food allergens
  4. GI symptoms total score of 8 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00557284

Contacts
Contact: Melinda Heffron, BA 303-224-4678 mheffron@1st-allergy.com

Locations
United States, Colorado
1st Allergy & Clinical Research Centers Recruiting
Centennial, Colorado, United States, 80112
Contact: Andrea L Beck, MA     303-224-4673     abeck@1st-allergy.com    
1st Allergy & Clinical Research Centers Recruiting
Thornton, Colorado, United States, 80229
Contact: Andrea L Beck, MA     303-224-4673     abeck@1st-allergy.com    
Sponsors and Collaborators
1st Allergy & Clinical Research Center
Merck
Investigators
Principal Investigator: Isaac R Melamed, MD 1st Allergy & Clinical Research Center
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: 32032
Study First Received: November 9, 2007
Last Updated: November 9, 2007
ClinicalTrials.gov Identifier: NCT00557284     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by 1st Allergy & Clinical Research Center:
Atopic Dermatitis (Eczema) associated with food allergies

Additional relevant MeSH terms:
Respiratory System Agents
Dermatitis, Atopic
Skin Diseases
Immune System Diseases
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Pharmacologic Actions
 Leukotriene Antagonists
Montelukast
Hypersensitivity
Genetic Diseases, Inborn
Therapeutic Uses
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis

ClinicalTrials.gov processed this record on November 22, 2009



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