Comparison of the Therapeutic Effect of the Combination Regimen of Oral Melatonin and Topical Betamethasone with Topical Betamethasone Alone in the Treatment of Atopic Dermatitis: A Randomized Clinical Trial

Atopic dermatitis is a common disease in infants and children which is chatacterized with pruritus and skin lesions and is known to be chronic and recurrent. Since the side effects caused by common treatments (topical corticosteroids) may cause a limitation to their long-term use, the need for alternative treatments is mandatory. Considering the anti-inflammatory effects, immune system, and sleep-regulating properties of melatonin, this study compared the effects of topical betamethasone alone with topical betamethasone combined with oral melatonin in the atopic treatment dermatitis.

This clinical trial was carried out on 50 patients with atopic dermatitis. Participants were randomly assigned to two treatment groups. The control group received betamethasone, and the intervention group, in addition to betamethasone, received 3 mg melatonin tablets for 12 weeks. The disease status of participants was also assessed using the Scoring Atopic Dermatitis (SCORAD) scale.

Both treatment groups showed significant changes in SCORAD score, affected area, disease intensity, and reported symptoms like insomnia and itching. So, the SCORAD index in the intervention and control groups decreased on average by 29.44 ± 14.09 and 33.56 ± 16.08, respectively, at the end of the treatment. But, no significant difference was observed between the two groups in these changes. Additionally, no specific treatment-related side effects also were reported during this study.

Although both treatment regimens resulted in significant improvement in the condition of atopic dermatitis, this study found no significant difference in the effectiveness of the two treatment regimens, suggesting the need for further investigation into alternative topical corticosteroid therapies to provide similar efficacy with reduced side effects.