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

Pediatr Allergy Immunol. 2018 Dec;29(8):834-840. doi: 10.1111/pai.12978. Epub 2018 Sep 28.


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 (β -3.55; 95% CI, -6.11, -0.98; P = 0.007), objective SCORAD index (β -3.23; 95% CI, -5.08, -1.38; P = 0.001), serum total IgE levels (β -153.94 ku/L; 95% CI, -260.39, -47.49; P = 0.005), and CSHQ scores (β -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.

Keywords: atopic dermatitis; disease severity; melatonin; sleep quality.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Child
  • Dermatitis, Atopic / drug therapy*
  • Dermatitis, Atopic / physiopathology
  • Double-Blind Method
  • Female
  • Humans
  • Immunoglobulin E / blood
  • Iran
  • Male
  • Melatonin / administration & dosage*
  • Severity of Illness Index
  • Sleep / drug effects*
  • Surveys and Questionnaires
  • Treatment Outcome


  • Immunoglobulin E
  • Melatonin