The effects of melatonin administration on disease severity and sleep quality in children with atopic dermatitis: A randomized, double-blinded, placebo-controlled trial

Background The aim of this clinical trial was to determine the effects of melatonin administration on disease severity and sleep quality in children diagnosed with atopic dermatitis (AD). Methods This randomized, double-blinded, placebo-controlled trial was conducted by recruiting 70 patients, aged 6-12 years, who had been diagnosed with AD. Study participants were randomly allocated into two intervention groups to receive either 6 mg/d melatonin supplements or placebo (n = 35 each group) for 6 weeks. Severity of disease was assessed using the scoring atopic dermatitis (SCORAD) and objective SCORAD indices. Sleep quality was evaluated by completing the Children's Sleep Habits Questionnaire (CSHQ). Results Following 6 weeks of intervention, melatonin supplementation significantly improved SCORAD index (beta -3.55; 95% CI, -6.11, -0.98; P = 0.007), objective SCORAD index (beta -3.23; 95% CI, -5.08, -1.38; P = 0.001), serum total IgE levels (beta -153.94 ku/L; 95% CI, -260.39, -47.49; P = 0.005), and CSHQ scores (beta -2.55; 95% CI, -4.34, -0.75; P = 0.006). However, melatonin had no significant impact on pruritus scores, high-sensitivity C-reactive protein (hs-CRP), sleep-onset latency, total sleep time, weight, and BMI compared with placebo. Conclusions Overall, melatonin supplementation had beneficial effects on disease severity, serum total IgE levels, and CSHQ among children diagnosed with AD.