Atopic dermatitis is a chronic inflammatory skin disease that is commonly associated with itching, sleep disturbance, and impaired quality of life. Melatonin may have beneficial effects on sleep, inflammation, and oxidative stress.
This randomized controlled trial will evaluate the effectiveness of oral melatonin as an adjunct to standard treatment in adults with atopic dermatitis. A total of 130 participants will be randomly assigned in a 1:1 ratio to receive either standard treatment according to the Vietnamese Ministry of Health 2023 guideline or standard treatment plus oral melatonin 6 mg once daily for 4 weeks.
Atopic dermatitis severity will be assessed using the SCORing Atopic Dermatitis (SCORAD) index, and sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (PSQI). Serum superoxide dismutase and melatonin concentrations will also be measured to assess changes related to oxidative stress and melatonin status. Participants will be evaluated at baseline and during the 4-week treatment period.
Age 18 years or older.
Diagnosed with atopic dermatitis according to the Hanifin and Rajka 1980 criteria, defined by the presence of at least 3 major criteria and 3 minor criteria.
Pruritus.
Typical morphology and distribution of skin lesions, including lichenified plaques commonly involving flexural areas.
Acute infectious disease.
Another skin disorder involving the same area as the atopic dermatitis lesions or the venipuncture site.
Serious systemic disease.
Known allergy or hypersensitivity to melatonin.
Parallel
Melatonin
Dietary supplementOral melatonin 6 mg, one tablet once daily, taken approximately 60 minutes before bedtime for 4 weeks, in addition to standard treatment for atopic dermatitis according to the Vietnamese Ministry of Health 2023 guideline.
Standard Treatment for Atopic Dermatitis
Other interventionStandard treatment for atopic dermatitis according to the Vietnamese Ministry of Health 2023 guideline. Treatment is selected according to disease stage and clinical condition and may include appropriate topical therapy, antihistamines, systemic corticosteroids when indicated, and antibiotics for secondary infection.
Change in SCORAD Score From Baseline to Week 4
Atopic dermatitis severity will be assessed using the SCORing Atopic Dermatitis (SCORAD) index. The total SCORAD score ranges from 0 to 103, with higher scores indicating greater disease severity. The change in total SCORAD score from baseline to Week 4 will be compared between the standard treatment group and the standard treatment plus melatonin group.
Change in SCORAD Score From Baseline to Week 2
Atopic dermatitis severity will be assessed using the SCORing Atopic Dermatitis (SCORAD) index. The change in total SCORAD score from baseline to Week 2 will be compared between the standard treatment group and the standard treatment plus melatonin group. Higher SCORAD scores indicate greater disease severity.
Change in Pittsburgh Sleep Quality Index Score From Baseline to Week 4
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. Change from baseline to Week 4 will be compared between treatment groups.
Change in Serum Superoxide Dismutase Concentration From Baseline to Week 4
Serum superoxide dismutase concentration will be measured before treatment and after 4 weeks to evaluate changes in oxidative stress-related antioxidant status.
Change in Serum Melatonin Concentration From Baseline to Week 4
Serum melatonin concentration will be measured before treatment and after 4 weeks. Changes from baseline will be evaluated and compared between treatment groups.
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