Atopic Dermatitis
Conditions
Keywords
atopic dermatitis, eczema
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.
Interventions
DIETARY_SUPPLEMENTMelatonin
melatonin 3 mg tab 1 tab po hs for 4 weeks
DIETARY_SUPPLEMENTPlacebo
starch pill
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective sleep measures as measured by actigraphs and SCORAD | 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
| Measure | Time frame | Description |
|---|---|---|
| urine and serum cytokines | 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 |
| total and allergen-specific IgE | 4 weeks | total serum IgE and allergen specific IgE to Derp, Derf, SEA, and SEB |
| sleep parameters measured by polysomnography | 4 weeks | sleep onset latency, sleep efficiency, wake episodes and duration, total sleep time, sleep stages, limb movement index |
| subjective improvement in symptoms | 4 weeks | subjective assessment of whether sleep and dermatitis improved after treatment |
Countries
Taiwan
Outcome results
None listed