Plaque psoriasis
Conditions
Interventions
patients will get methotrexate 15mg/wk, folic acid 5 mg/d and circadin 2 mg/day ,patients will get methotrexate 15 mg/wk, folic acid 5 mg/d + placebo
Experimental Drug,Placebo Comparator No treatment
Sponsors
None
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Patients diagnosed with plaque psoriasis of moderate to severe severity, male or female, aged 18 years or older. 2. Volunteers who willingly participate in the study and have signed a written informed consent form. 3.Patients with a baseline creatinine clearance greater than 60 mL/min/1.73 sq.m
Exclusion criteria
Exclusion criteria: 1. Patients with guttate psoriasis, erythrodermic psoriasis, or pustular psoriasis. 2. Patients who have used topical psoriasis treatments within 2 weeks prior to screening. 3. Patients who have received phototherapy or systemic therapy for psoriasis within 4 weeks prior to screening. 4. Patients who have received biologic therapy within 6 months prior to screening. 5. Patients with severe renal or hepatic impairment. 6.Patients with acute or chronic infections, such as viral hepatitis or tuberculosis. 7.Patients with psychiatric disorders, insomnia, or other medical conditions that may interfere with the assessment of study outcomes. 8.Pregnant or breastfeeding women. 9. Patients planning to become pregnant during the study or within 3 months after study completion. 10.Patients with a history of hypersensitivity to melatonin. 11.Patients with a history of hypersensitivity to methotrexate. 12.Patients who are unable to comply with study visits and follow-up evaluations throughout the study duration. 13.Patients who are currently receiving systemic treatment for psoriasis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Psoriasis Area and Severity Index (PASI) Weeks 0, 2, 4, 8, and 12 Total score 0 to 72, assessed by a dermatologist | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI) week 0,12 Total score 0 to 21, self-administered questionnaire,Epworth Sleepiness Scale (ESS) week 0 , 12 Total score 0 to 24, self-administered questionnaire,Dermatology Life Quality Index (DLQI) week 0,12 Total score 0 to 30, self-administered questionnaire,Adverse events week 0,2,12 number and proportion of participants with AEs/SAEs; include laboratory parameters | — |
Countries
Thailand
Contacts
Public Contactcholada waikittipong
Chulabhorn International College of Medicine
Outcome results
None listed