Effectiveness of Oral Melatonin as an Adjunct to Standard Treatment in Adults With Atopic Dermatitis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 130
- 主要终点
- Change in SCORAD Score From Baseline to Week 4
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Standard Treatment Plus 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.
干预措施: Standard Treatment for Atopic Dermatitis (Other)
Standard Treatment Plus 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.
干预措施: Melatonin (Dietary Supplement)
Standard Treatment
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.
干预措施: Melatonin (Dietary Supplement)
结局指标
主要结局
Change in SCORAD Score From Baseline to Week 4
时间窗: 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.
次要结局
- 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)
- Adverse Events During Treatment(Baseline through Week 4)