Effectiveness of Melatonin for Sleep Disturbances in Children With Atopic Dermatitis

This study has been completed.
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
First received: July 8, 2012
Last updated: April 16, 2015
Last verified: April 2015

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.

Condition Intervention Phase
Atopic Dermatitis
Dietary Supplement: Melatonin
Dietary Supplement: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Melatonin Supplement in the Management of Sleep Disturbances in Children With Atopic Dermatitis

Resource links provided by NLM:

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Objective sleep measures as measured by actigraphs and SCORAD [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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:
  • urine and serum cytokines [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    total serum IgE and allergen specific IgE to Derp, Derf, SEA, and SEB

  • sleep parameters measured by polysomnography [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    sleep onset latency, sleep efficiency, wake episodes and duration, total sleep time, sleep stages, limb movement index

  • subjective improvement in symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    subjective assessment of whether sleep and dermatitis improved after treatment

Enrollment: 48
Study Start Date: January 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Starch pill Dietary Supplement: Placebo
starch pill
Experimental: Melatonin Dietary Supplement: Melatonin
melatonin 3 mg tab 1 tab po hs for 4 weeks


Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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:

  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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01638234

National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Jyh-Hong Lee, MD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01638234     History of Changes
Other Study ID Numbers: 200902026M
Study First Received: July 8, 2012
Last Updated: April 16, 2015
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
atopic dermatitis

Additional relevant MeSH terms:
Dermatitis, Atopic
Sleep Disorders
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Immune System Diseases
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 02, 2015