Melatonin Supplementation for Children With Atopic Dermatitis and Sleep Disturbance: A Randomized Clinical Trial.

Randomized, placebo-controlled crossover clinical trial in children and adolescents aged 1 to 18 years with physician-diagnosed atopic dermatitis involving at least 5% of body surface area and sleep disturbance. Participants were recruited from pediatric and dermatology clinics at National Taiwan University Hospital in Taiwan between August 1, 2012 and January 31, 2013.

Oral melatonin, 3 mg/day, taken at bedtime for 4 weeks, followed by a 2-week washout and crossover to the alternate treatment for another 4 weeks. The comparator was placebo.

Melatonin improved both sleep and atopic dermatitis severity versus placebo, with no adverse events reported. SCORAD improved more with melatonin than placebo, with a between-group difference of -9.1 (-13.7 to -4.6; P < .001), and objective SCORAD showed a difference of -8.7 (-12.6 to -4.8; P < .001). Sleep-onset latency also decreased more with melatonin, with a between-group difference of -21.4 (-38.6 to -4.2; P = .02). Urinary 6-sulfatoxymelatonin increased significantly after melatonin versus placebo (P < .001), while total IgE and allergen-specific IgE did not differ.

Single-center trial with a small sample and short treatment periods limits generalizability and precision. The crossover design and incomplete completion of the crossover phase, with 38 participants (79%) completing it, may reduce robustness of the estimates.