NCT07842900Not yet recruiting
Oral Melatonin as Adjunctive Therapy in Adults With Atopic Dermatitis
Effectiveness of Oral Melatonin as an Adjunct to Standard Treatment in Adults With Atopic Dermatitis: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 21 Sept 2026
- Start date
- 10 Oct 2026
- Primary completion date
- 10 Oct 2027
- Lead sponsor
- Can Tho University of Medicine and Pharmacy
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07842900
What you commit to
- Study type: Interventional
- Planned participants: 130
- From 10 Oct 2026 to the primary completion date, 10 Oct 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Immunodeficiency, including HIV/AIDS, diabetes mellitus, or previous use of immunosuppressive drugs.
- Use of glutathione, vitamin C, vitamin E, zinc, iron, or folic acid within 3 months before or during data collection.
- Use of medication for insomnia or antidepressant medication within 4 weeks before or during data collection.
Other illness
- 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.
- Severe coagulation disorder or use of high-dose anticoagulant therapy.
- Neurological or psychiatric disorders, or any other medical condition that may cause sleep problems.
Age
- Age younger than 18 years.
Other
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.