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Effectiveness of Melatonin for Sleep Disturbances in Children With Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01638234
Recruitment Status : Completed
First Posted : July 11, 2012
Last Update Posted : April 20, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Dietary Supplement: Melatonin Dietary Supplement: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Melatonin Supplement in the Management of Sleep Disturbances in Children With Atopic Dermatitis
Study Start Date : January 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01638234

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: National Taiwan University Hospital Identifier: NCT01638234     History of Changes
Other Study ID Numbers: 200902026M
First Posted: July 11, 2012    Key Record Dates
Last Update Posted: April 20, 2015
Last Verified: April 2015

Keywords provided by National Taiwan University Hospital:
atopic dermatitis

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