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NOT YET RECRUITING
NCT07842900
NA

Oral Melatonin as Adjunctive Therapy in Adults With Atopic Dermatitis

Sponsor: Can Tho University of Medicine and Pharmacy

View on ClinicalTrials.gov

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.

Official title: Effectiveness of Oral Melatonin as an Adjunct to Standard Treatment in Adults With Atopic Dermatitis: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2026-10-10

Completion Date

2027-12-10

Last Updated

2026-09-25

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Melatonin

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.

OTHER

Standard Treatment for Atopic Dermatitis

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.