Effectiveness of Melatonin for Sleep Disturbances in Children With Atopic Dermatitis

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Melatonin

• Registration Number: NCT01638234
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-07-08
• Study First Submitted QC: 2012-07-08
• Study First Posted: 2012-07-11
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-16
• Last Update Posted: 2015-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

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Exclusion Criteria

1. Those who had failed other systemic and/or topical immunosuppressive agents such as tacrolimus, methotrexate, or cyclosporine
2. Those who had received therapy for insomnia within 4 weeks before the baseline visit
3. Those who were, in the opinion of the investigator, known to be unreliable or noncompliant with medical treatment or appointments
4. Those who had drug abuse problems, mental health dysfunction, or other factors limiting their ability to cooperate fully
5. Those who were taking antihistamines, oral immunosuppressant medication, or antidepressant medication
6. Pregnant and lactating women and those who are presently planning to get pregnant
7. 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Starch pill	Placebo	-
Melatonin	Melatonin	-

Primary Outcome Measures

Name	Time	Method
Objective sleep measures as measured by actigraphs and SCORAD	4 weeks	actigraph parameters including sleep latency, sleep efficiency, total sleep time, and wake episodes and duration; SCORAD and objective SCORAD for disease severity assessment

Secondary Outcome Measures

Name	Time	Method
urine and serum cytokines	4 weeks	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
total and allergen-specific IgE	4 weeks	total serum IgE and allergen specific IgE to Derp, Derf, SEA, and SEB
sleep parameters measured by polysomnography	4 weeks	sleep onset latency, sleep efficiency, wake episodes and duration, total sleep time, sleep stages, limb movement index
subjective improvement in symptoms	4 weeks	subjective assessment of whether sleep and dermatitis improved after treatment

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan