Efficacy of Melatonin and Diphenhydramine Versus Placebo in Treatment of Nighttime Pruritus in Atopic Dermatitis
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 主要终点
- POEM (Patient Oriented Eczema Measure)
研究概览
简要总结
This study will look at melatonin vs. first generation antihistamine vs. placebo in improving nighttime itching in children with atopic dermatitis.
详细描述
This will be a 6 week study to determine the efficacy of melatonin vs. first generation antihistamine vs. placebo in improving nighttime pruritus in children with atopic dermatitis.
Secondary aims will include:
- Determine efficacy of melatonin vs. first generation antihistamine in management of sleep disturbance in children with atopic dermatitis
- Compare differences between treatment groups in disease improvement
- Compare differences between treatment groups in quality of life
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
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Physician diagnosed eczema covering more than 5% of body surface area
- •Ages 2-12 years old
排除标准
- •Sleep disorder, including underlying insomnia
- •Neuropsychiatric disorder
- •Condition that requires use of antihistamines
- •On systemic eczema therapy or monoclonal antibody for allergic diseases
- •Unable to discontinue other antihistamine use
- •Autoimmune disease as melatonin is contraindicated
研究组 & 干预措施
Melatonin Treatment
Subjects to receive melatonin 0.1 mg/kg (minimum dose of 1 mg, maximum dose of 5 mg) 30 minutes prior to bedtime (1 mg/ml oral compound suspension) for 4 weeks.
干预措施: Melatonin (Drug)
Diphenhydramine Treatment
Subject to receive diphenhydramine 2.5 mg/ml oral liquid, dosed at 1 mg/kg at bedtime for 4 weeks.
干预措施: Diphenhydramine (Drug)
Placebo
Subjects will receive cherry flavored placebo at bedtime for 4 weeks.
干预措施: Placebos (Drug)
结局指标
主要结局
POEM (Patient Oriented Eczema Measure)
时间窗: 6 weeks
This survey is a total of 7 questions that assesses the quality of life of patient's with eczema to determine their disease severity. The 7 questions are scored out of 4 points. A higher total score indicates a higher severity of disease.
EASI score
时间窗: 6 weeks
This tool is also used to assess severity of eczema. 4 different body regions are scored based on the percentage of eczema affecting the area. The calculations for each region are severity score x area score x known multiplier. A higher score indicates a higher severity of disease.
次要结局
- 5D Pruritus survey(6 weeks)
- ESS-CHAD(6 weeks)
- Actigraphy(6 weeks)