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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean Change in PADC (Caregivers Perception of Disease Control)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Year 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
1
Montelukast
干预措施: Montelukast (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change in PADC (Caregivers Perception of Disease Control)
时间窗: Baseline and 9 weeks
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)
Mean Change in Investigator Global Assessment (IGA)
时间窗: Baseline and 9 weeks
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.
Mean Change in Pruritus
时间窗: Baseline and 9 weeks
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.
Change in Percentage of Body Involvement
时间窗: Baseline and 9 weeks
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
Mean Change in Weekly Use of Rescue Medication for AD Flare-up - Cetirizine and/or 10% Hydrocortisone Cream
时间窗: Baseline and 9 weeks
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).
次要结局
- Mean Change in (Gastrointestinal Symptom Rating Scale) GSRS(Baseline and 9 weeks)
- Mean Change in Serum and Urinary Inflammatory Marker Levels(Baseline and 9 weeks)
- Mean Change in Serum IgE Levels(Baseline and 9 weeks)
研究者
Isaac Melamed
Principle Investigator
1st Allergy & Clinical Research Center