Effectiveness of Melatonin for Sleep Disturbances in Children With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01638234
• Other study ID #: 200902026M
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 8, 2012
• Last updated: April 16, 2015
• Start date: January 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2015
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Dyssomnias
• Eczema
• Parasomnias
• Sleep Disorders

Intervention

Dietary Supplement:
• Melatonin
melatonin 3 mg tab 1 tab po hs for 4 weeks
• Placebo
starch pill

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective sleep measures as measured by actigraphs and SCORAD	actigraph parameters including sleep latency, sleep efficiency, total sleep time, and wake episodes and duration; SCORAD and objective SCORAD for disease severity assessment	4 weeks	No
Secondary	urine and serum cytokines	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	4 weeks	No
Secondary	total and allergen-specific IgE	total serum IgE and allergen specific IgE to Derp, Derf, SEA, and SEB	4 weeks	No
Secondary	sleep parameters measured by polysomnography	sleep onset latency, sleep efficiency, wake episodes and duration, total sleep time, sleep stages, limb movement index	4 weeks	No
Secondary	subjective improvement in symptoms	subjective assessment of whether sleep and dermatitis improved after treatment	4 weeks	No