Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Isaac Melamed, M.D., 1st Allergy & Clinical Research Center
ClinicalTrials.gov Identifier:
NCT00557284
First received: November 9, 2007
Last updated: January 25, 2012
Last verified: January 2012

November 9, 2007
January 25, 2012
March 2008
May 2009   (final data collection date for primary outcome measure)
The change in validated skin assessment scores (EASI) in treating symptoms of atopic dermatitis associated with food allergens [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
The change in validated skin assessment scores (EASI) in treating symptoms of atopic dermatitis associated with food allergens [ Time Frame: 9 weeks ]
Complete list of historical versions of study NCT00557284 on ClinicalTrials.gov Archive Site
  • The change in serum and urinary inflammatory marker levels [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • The change in GSRS validated scale for treating gastrointestinal symptoms induced by food allergens [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Atopic Dermatitis
  • 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
  • Drug: Placebo
    Oral granules or chewable tablet, POQD
  • Experimental: 1
    Intervention: Drug: Montelukast
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2009
May 2009   (final data collection date for primary outcome measure)

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 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.
Both
1 Year to 8 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00557284
32032
No
Isaac Melamed, M.D., 1st Allergy & Clinical Research Center
1st Allergy & Clinical Research Center
Merck Sharp & Dohme Corp.
Principal Investigator: Isaac R Melamed, MD 1st Allergy & Clinical Research Center
1st Allergy & Clinical Research Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP