Phase 4
N=20
Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT00557284 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Change in Percentage of Body Involvement — -2.0; 0.15 Change of percentage in body involvement
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Montelukast (Drug); Placebo (Drug)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- 1st Allergy & Clinical Research Center
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Percentage of Body Involvement |
-2.0; 0.15 | — |
| PRIMARY Mean Change in Investigator Global Assessment (IGA) |
-.11; -.70 | — |
| PRIMARY Mean Change in PADC (Caregivers Perception of Disease Control) |
-.78; -0.10 | — |
| PRIMARY Mean Change in Pruritus |
-0.82; 0.32 | — |
| PRIMARY Mean Change in Weekly Use of Rescue Medication for AD Flare-up - Cetirizine and/or 10% Hydrocortisone Cream |
-0.56; 0.91; 0.78; 2.0 | — |
| SECONDARY Mean Change in Serum and Urinary Inflammatory Marker Levels |
-9.0; -7.9; 2.3; -16.4; 30.9; -58.8 | — |
| SECONDARY Mean Change in Serum IgE Levels |
100.5; 216.1 | — |
| SECONDARY Mean Change in (Gastrointestinal Symptom Rating Scale) GSRS |
-3.03; -4.1 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00557284). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.