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

National Taiwan University Hospital1 site in 1 country48 target enrollmentJanuary 2012

ConditionsAtopic Dermatitis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Atopic Dermatitis
Sponsor: National Taiwan University Hospital
Enrollment: 48
Locations: 1
Primary Endpoint: Objective sleep measures as measured by actigraphs and SCORAD
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

April 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

National Taiwan University Hospital

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Objective sleep measures as measured by actigraphs and SCORAD

Time Frame: 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