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

November 9, 2007
November 9, 2007
November 2007
 
The change in validated skin assessment scores (EASI) in treating symptoms of atopic dermatitis associated with food allergens [ Time Frame: 9 weeks ]
Same as current
No Changes Posted
  • 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 ]
Same as current
 
Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens
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

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.

 
Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Atopic Dermatitis
  • Drug: Montelukast
  • Drug: Placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
20
March 2008
 

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.
Both
1 Year to 8 Years
No
Contact: Melinda Heffron, BA 303-224-4678 mheffron@1st-allergy.com
United States
 
NCT00557284
 
32032
1st Allergy & Clinical Research Center
Merck
Principal Investigator: Isaac R Melamed, MD 1st Allergy & Clinical Research Center
1st Allergy & Clinical Research Center
November 2007

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