Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens

NCT00557284 | Completed Phase 4 Results

• 1 other identifier: 32032
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis (Eczema) associated with food allergies

Outcome Measures

Primary Outcomes (5)

• Change in Percentage of Body Involvement

  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

  Baseline and 9 weeks

• Mean Change in Investigator Global Assessment (IGA)

  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.

  Baseline and 9 weeks

• Mean Change in PADC (Caregivers Perception of Disease Control)

  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)

  Baseline and 9 weeks

• Mean Change in Pruritus

  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.

  Baseline and 9 weeks

• Mean Change in Weekly Use of Rescue Medication for AD Flare-up - Cetirizine and/or 10% Hydrocortisone Cream

  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).

  Baseline and 9 weeks

Secondary Outcomes (3)

• Mean Change in Serum and Urinary Inflammatory Marker Levels

  Baseline and 9 weeks

• Mean Change in Serum IgE Levels

  Baseline and 9 weeks

• Mean Change in (Gastrointestinal Symptom Rating Scale) GSRS

  Baseline and 9 weeks

Study Arms (2)

1

EXPERIMENTAL

Montelukast

Drug: Montelukast

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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

1

Placebo DRUG

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

2

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• 1st Allergy & Clinical Research Center: lead

Study Sites (2)

1st Allergy & Clinical Research Centers

Centennial, Colorado, 80112, United States

Location

1st Allergy & Clinical Research Centers

Thornton, Colorado, 80229, United States

Location

Related Links

• Research website

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

montelukast

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Isaac Melamed, principle investigator
• Organization: IMMUNOe International Research Centers

melamedi@immunoe.com

303-773-9000

Study Officials

• Isaac R Melamed, MD

  1st Allergy & Clinical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 9, 2007
• First Posted: November 12, 2007
• Study Start: March 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: April 21, 2015
• Results First Posted: December 9, 2014

Record last verified: 2015-03

Locations

US (2)