Atopic DermatitisMEL-ADNCT07842900
Oral Melatonin as Adjunctive Therapy in Adults With Atopic Dermatitis
A study testing Melatonin and Standard Treatment for Atopic Dermatitis in people with Atopic Dermatitis, run by Can Tho University of Medicine and Pharmacy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Melatonin and Standard Treatment for Atopic Dermatitis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2026to 10 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Oral Melatonin as an Adjunct to Standard Treatment in Adults With Atopic Dermatitis: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Atopic Dermatitis
- Being tested
- Melatonin, Standard Treatment for Atopic Dermatitis
- Keywords
- Melatonin, SCORAD, Pittsburgh Sleep Quality Index, PSQI, Superoxide Dismutase, Oxidative Stress, Sleep Quality, Adjunctive Therapy, Randomized Controlled Trial
- Medical subject headings
- Dermatitis, Atopic, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDietary supplement
Oral 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 DermatitisOther
Standard 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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | Active comparator | Participants will receive standard treatment for atopic dermatitis according to the Vietnamese Ministry of Health 2023 guideline. Treatment will be selected according to disease stage and clinical condition and may include appropriate topical therapy, antihistamines, systemic corticosteroids when indicated, and antibiotics in cases of secondary infection. Receives: Dietary Supplement: Melatonin |
| Standard Treatment Plus Melatonin | Experimental | Participants will receive the same standard treatment for atopic dermatitis as the active comparator group plus oral melatonin 6 mg once daily for 4 weeks. Melatonin will be taken approximately 60 minutes before bedtime. Receives: Dietary Supplement: Melatonin; Other: Standard Treatment for Atopic Dermatitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 4
Secondary outcomes (6)
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.
Measured: Baseline to Week 2
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.
Measured: Baseline to Week 4
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.
Measured: Baseline to Week 4
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.
Measured: Baseline to Week 4
Clinical Treatment Response According to SCORAD
Treatment response will be categorized according to the study protocol as good, moderate, or poor/no response based on improvement in clinical manifestations, change in total SCORAD score, and change in disease severity category.
Measured: Week 2 and Week 4
Adverse Events During Treatment
The number and proportion of participants experiencing treatment-related adverse effects, including adverse effects associated with melatonin and concomitant treatments, will be recorded.
Measured: Baseline through Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start10 Oct 2026 (estimated)
- Primary completion10 Oct 2027 (estimated)
- Study completion10 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Can Tho University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842900
- Sponsor's protocol ID
- 25.0021.NCS-ĐHYDCT
- Acronym
- MEL-AD
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No