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Melatonin Supplementation in Adult Patients With Atopic Dermatitis: A Randomized Clinical Trial

Zinat Heidari, G. Gharibi, Hoorieh Alaeen, Elliyeh Ghadrdan, Ehsan Shahrestanaki, Zeynab Sadeghi-Ghadi, A. Sahebkar, M. Daei

Journal of Pineal Research, 2026

32 participants · 1 citation

Abstract

This study aimed to evaluate the effects of melatonin supplementation on disease severity, sleep quality, and quality of life in adult patients with atopic dermatitis (AD). This study was designed as a randomized, double‐blind, placebo‐controlled clinical trial involving adult patients with mild to moderate AD. Eligible participants were randomly assigned to receive either a 10 mg melatonin tablet or a matching placebo once daily for 4 weeks. The primary outcome was the severity of AD, assessed by SCORAD index at baseline and after 4 weeks of supplementation. Secondary outcomes included the intensity of pain (NPRS), pruritus severity (Pruritus‐NRS), sleep quality (ADSS), and quality of life (DLQI). Eighty patients completed the study. The mean age (Standard deviation) of the patients was 33.26 (12.57) years, and 32 patients (40%) were male. The SCORAD, Pruritus‐NRS, 12‐PSS, ADSS, and DLQI indices improved significantly (p‐values of < 0.001, 0.006, 0.011, < 0.05, and 0.003, respectively) after 4 weeks of supplementation. However, melatonin supplementation did not improve the NPRS (p‐value: 0.063). No patient reported an adverse effect throughout the study. Melatonin supplementation in adult patients with mild to moderate AD effectively improved disease severity, sleep quality, and quality of life, without any reported adverse effects. However, due to limitations of our study, further research is required to confirm these findings.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 32 participants or records.

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