Oral Melatonin as Adjunctive Therapy in Adults With Atopic Dermatitis

Atopic dermatitis is a chronic, relapsing inflammatory skin disease characterized by pruritus and inflammatory skin lesions. Sleep disturbance is common in patients with atopic dermatitis and may be related to both disease activity and alterations in circadian and oxidative stress pathways.

Melatonin is involved in the regulation of the sleep-wake cycle and also has antioxidant, anti-inflammatory, and immunomodulatory properties. These effects provide a biological rationale for evaluating melatonin as an adjunctive treatment in atopic dermatitis.

In this study, adults diagnosed with atopic dermatitis who meet the eligibility criteria will be randomly allocated to one of two parallel treatment groups. The control group will receive standard treatment for atopic dermatitis according to the Vietnamese Ministry of Health 2023 guideline. The experimental group will receive the same standard treatment plus oral melatonin 6 mg once daily, taken approximately 60 minutes before bedtime.

Participants will be followed for 4 weeks. Clinical disease severity will be assessed using the SCORAD index at baseline, Week 2, and Week 4. Sleep quality will be evaluated using the PSQI at baseline and Week 4. Serum superoxide dismutase and melatonin concentrations will be measured before treatment and after 4 weeks of treatment. Adverse effects occurring during treatment will also be recorded.

The study will compare changes in clinical severity, sleep quality, and biological markers between the two treatment groups to determine whether adjunctive oral melatonin provides additional benefit over standard treatment alone.

Inclusion criteria

• 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.
• Major criteria include:

• Pruritus.
• Typical morphology and distribution of skin lesions, including lichenified plaques commonly involving flexural areas.
• Chronic or chronically relapsing dermatitis.
• Personal or family history of atopic disease, including asthma, allergic rhinitis, or atopic dermatitis.
• Minor criteria may include xerosis, ichthyosis vulgaris, immediate skin test reactivity, elevated serum IgE, early age of onset, tendency toward skin infections, nonspecific hand or foot dermatitis, nipple eczema, cheilitis, recurrent conjunctivitis, Dennie-Morgan infraorbital fold, keratoconus, anterior subcapsular cataract, periorbital darkening, facial erythema or pallor, pityriasis alba, anterior neck folds, itching with sweating, intolerance to wool or lipid solvents, perifollicular hyperkeratosis, food allergy, disease course influenced by environmental or psychological factors, or white dermographism.
• Willing and able to provide informed consent.

Exclusion criteria

• 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.
• Immunodeficiency, including HIV/AIDS, diabetes mellitus, or previous use of immunosuppressive drugs.
• Severe coagulation disorder or use of high-dose anticoagulant therapy.
• Use of glutathione, vitamin C, vitamin E, zinc, iron, or folic acid within 3 months before or during data collection.
• Neurological or psychiatric disorders, or any other medical condition that may cause sleep problems.
• Use of medication for insomnia or antidepressant medication within 4 weeks before or during data collection.
• Pregnancy or breastfeeding.
• Age younger than 18 years.