An interventional study of Melatonin and Standard Treatment for Atopic Dermatitis in Atopic Dermatitis, sponsored by Can Tho University of Medicine and Pharmacy. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Can Tho University of Medicine and Pharmacy · Not applicable, Interventional, and Treatment
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.
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.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 130 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Can Tho University of Medicine and Pharmacy is the lead sponsor of 35 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Major criteria include:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Melatonin
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.
Dietary Supplement: Melatonin · Other: Standard Treatment for Atopic Dermatitis
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 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.
Time frame: Baseline to Week 4
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline through Week 4
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.
Of 113 non-industry interventional studies with no phase under Dermatitis, Atopic, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 12 months is below that.
Counting every sponsor, half of 182 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Can Tho University of Medicine and Pharmacy