Effectiveness of Melatonin for Sleep Disturbances in Children With Atopic Dermatitis

Study Overview
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Brief Summary
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Sleep disturbance is a common complaint among patients with atopic dermatitis(AD). Melatonin may aid sleep and also has anti-inflammatory properties, and has been suggested in managing sleep disturbance in AD patients. However, there has been no large randomized controlled trials. Hence the objective of this double-blind randomized controlled study is to determine whether supplementing melatonin is effective in improving sleep problems in children with AD.

Official Title
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Effectiveness of Melatonin Supplement in the Management of Sleep Disturbances in Children With Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Dietary Supplement: Melatonin
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children between 1 and 18 years of age with mild to moderate AD, affecting at least 5% of total body surface area, and with sleep problems in the previous 3 months Exclusion Criteria: Those who had failed other systemic and/or topical immunosuppressive agents such as tacrolimus, methotrexate, or cyclosporine Those who had received therapy for insomnia within 4 weeks before the baseline visit Those who were, in the opinion of the investigator, known to be unreliable or noncompliant with medical treatment or appointments Those who had drug abuse problems, mental health dysfunction, or other factors limiting their ability to cooperate fully Those who were taking antihistamines, oral immunosuppressant medication, or antidepressant medication Pregnant and lactating women and those who are presently planning to get pregnant Those who had any other condition or earlier/current treatment which, in the opinion of the investigator, would render the participant ineligible for the study

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Starch pill<br> | Dietary Supplement: Placebo<br>* starch pill<br>|
| Experimental: Melatonin<br> | Dietary Supplement: Melatonin<br>* melatonin 3 mg tab 1 tab po hs for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective sleep measures as measured by actigraphs and SCORAD | actigraph parameters including sleep latency, sleep efficiency, total sleep time, and wake episodes and duration; SCORAD and objective SCORAD for disease severity assessment | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urine and serum cytokines | serum levels of melatonin, urinary levels of 6-hydroxymelatonin sulfate, and serum levels of cytokines associated with sleep regulation including IL-10, IL-6, IL-4, IL-1b, and IL-31 | 4 weeks | 
| total and allergen-specific IgE | total serum IgE and allergen specific IgE to Derp, Derf, SEA, and SEB | 4 weeks | 
| sleep parameters measured by polysomnography | sleep onset latency, sleep efficiency, wake episodes and duration, total sleep time, sleep stages, limb movement index | 4 weeks | 
| subjective improvement in symptoms | subjective assessment of whether sleep and dermatitis improved after treatment | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atopic dermatitis, eczema