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Completed

NCT Number: NCT01638234

Effectiveness of Melatonin for Sleep Disturbances in Children With Atopic Dermatitis

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

melatonin

Dietary Supplement

melatonin 3 mg tab 1 tab po hs for 4 weeks

Placebo

Dietary Supplement

starch pill

Primary outcomes

  1. 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

Secondary outcomes

  1. urine and serum cytokines

    Time frame: 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

  2. total and allergen-specific IgE

    Time frame: 4 weeks

    total serum IgE and allergen specific IgE to Derp, Derf, SEA, and SEB

  3. sleep parameters measured by polysomnography

    Time frame: 4 weeks

    sleep onset latency, sleep efficiency, wake episodes and duration, total sleep time, sleep stages, limb movement index

  4. subjective improvement in symptoms

    Time frame: 4 weeks

    subjective assessment of whether sleep and dermatitis improved after treatment

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 11, 2012
Registry last updated
Apr 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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