Oral Melatonin as Adjunctive Therapy in Adults With Atopic Dermatitis

NCT07842900 | Not Yet Recruiting

• 1 other identifier: 25.0021.NCS-ĐHYDCT
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Atopic Dermatitis

Keywords

Melatonin; SCORAD; Pittsburgh Sleep Quality Index; PSQI; Superoxide Dismutase; Oxidative Stress; Sleep Quality; Adjunctive Therapy; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Week 4

Secondary Outcomes (6)

• Change in SCORAD Score From Baseline to Week 2

  Baseline to Week 2

• Change in Pittsburgh Sleep Quality Index Score From Baseline to Week 4

  Baseline to Week 4

• Change in Serum Superoxide Dismutase Concentration From Baseline to Week 4

  Baseline to Week 4

• Change in Serum Melatonin Concentration From Baseline to Week 4

  Baseline to Week 4

• Clinical Treatment Response According to SCORAD

  Week 2 and Week 4

Study Arms (2)

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.

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.

Dietary Supplement: Melatonin; Other: Standard Treatment for Atopic Dermatitis

Interventions

Melatonin DIETARY_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; Standard Treatment Plus Melatonin

Standard Treatment for Atopic Dermatitis OTHER

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.

Standard Treatment Plus Melatonin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Can Tho University of Medicine and Pharmacy: lead

MeSH Terms

Conditions

Dermatitis, Atopic; Sleep Initiation and Maintenance Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Trang Thi Thuy Trang, MD

CONTACT

0817973398; nthithuytrang@ctump.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 25, 2026
• Study Start (Estimated): October 10, 2026
• Primary Completion (Estimated): October 10, 2027
• Study Completion (Estimated): December 10, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share