Treatment of Nighttime Pruritus in Atopic Dermatitis

Study Overview
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Brief Summary
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This study will look at melatonin vs. first generation antihistamine vs. placebo in improving nighttime itching in children with atopic dermatitis.

Detailed Description
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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

Official Title
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Efficacy of Melatonin and Diphenhydramine Versus Placebo in Treatment of Nighttime Pruritus in Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Melatonin
* Drug: Diphenhydramine
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physician diagnosed eczema covering more than 5% of body surface area Ages 2-12 years old Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Melatonin Treatment<br>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. | Drug: Melatonin<br>* Drug to be administered for 4 weeks. Subjects will complete surveys prior to initiation and at the end of the study that will assess severity of eczema, quality of life, severity of itch, and sleep quality.<br>* Other names: generic;|
| Active Comparator: Diphenhydramine Treatment<br>Subject to receive diphenhydramine 2.5 mg/ml oral liquid, dosed at 1 mg/kg at bedtime for 4 weeks. | Drug: Diphenhydramine<br>* Drug to be administered for 4 weeks. Subjects will complete surveys prior to initiation and at the end of the study that will assess severity of eczema, quality of life, severity of itch, and sleep quality.<br>* Other names: Benadryl;|
| Placebo Comparator: Placebo<br>Subjects will receive cherry flavored placebo at bedtime for 4 weeks. | Drug: Placebos<br>* Drug to be administered for 4 weeks. Subjects will complete surveys prior to initiation and at the end of the study that will assess severity of eczema, quality of life, severity of itch, and sleep quality.<br>* Other names: generic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POEM (Patient Oriented Eczema Measure) | 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. | 6 weeks | 
| EASI score | 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. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5D Pruritus survey | This survey is a 5 question survey to assess severity of itch in patient's with eczema. The higher the score the worse the pruritus is and the more it affects the patient on a daily basis. | 6 weeks | 
| ESS-CHAD | This questionnaire is a series of questions that assesses sleepiness. Patient's can rank the situations based on a 3 point scale, 0 indicating would never doze and 3 indicating a high chance of dozing. A higher score indicates increased sleepiness. | 6 weeks | 
| Actigraphy | This device is worn on the wrist of a patient like a watch and records sleep-wake cycles. | 6 weeks |