Effectiveness of Melatonin for Sleep Disturbances in Children With Atopic Dermatitis
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
48 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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