Psoriasis (scalp location)
Conditions
Interventions
Treatment Group:Secukinumab, administered via subcutaneous injection at a dose of 240 mg, with injections given at weeks 0, 2, 4, 8, 12, 16, 20, and 24.
Sponsors
First Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for scalp psoriasis specified in the Chinese Clinical Guidelines for the Diagnosis and Treatment of Psoriasis, with or without plaque psoriasis; 2. Aged 18–60 years, no gender restriction; 3. Plaque psoriasis with BSA =5% or Psoriasis Area and Severity Index (PASI) =12; 4. Psoriasis Scalp Severity Index, PSSI =4 score.
Exclusion criteria
Exclusion criteria: 1. Having other types of psoriasis, such as guttate psoriasis, pustular psoriasis, and erythrodermic psoriasis; suffering from drug-induced psoriasis (including but not limited to new-onset psoriasis or exacerbation of psoriasis induced by beta-blockers, calcium channel inhibitors, or lithium preparations); 2. Subjects with other skin diseases that may interfere with clinical evaluation (e.g., severe cutaneous bacterial, fungal, viral infections, etc.); 3. Active autoimmune inflammatory diseases, such as mixed connective tissue disease, idiopathic inflammatory myopathy, etc.; history of congenital or acquired immunodeficiency; 4. History of chronic diarrhea, severe digestive system diseases (such as active gastric ulcer, gastrointestinal bleeding, etc.), or inflammatory bowel disease (including Crohn’s disease, ulcerative colitis, etc.); 5. Female subjects who are pregnant or breastfeeding, or plan to become pregnant during the trial; subjects who plan to donate sperm or ova during the trial; and fertile subjects (defined as having the physiological capacity for conception) who are unwilling to take contraceptive measures throughout the trial period and within six months after the last administration of the investigational product; 6. Severe or systemic infection occurring within 4 weeks prior to enrollment that requires oral and/or intravenous anti-infective treatment, or hospitalization due to infection; 7. During screening, the subject's medical history, symptoms, and examination results indicate active tuberculosis; 8. Within 3 months prior to randomization, history of moderate to severe congestive heart failure (New York Heart Association [NYHA] functional class =3), or occurrence of cardiovascular/cerebrovascular events or severe bleeding events; 9. History of malignancy in any organ system within 5 years prior to randomization, excluding malignancies with low risk of metastasis and death, such as adequately treated carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin, etc.; subject has a history of depression; 10. History of psychiatric disorders, such as depression, etc.; 11. Laboratory findings meeting any of the following criteria: 1. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 × upper limit of normal (ULN); 2. Serum creatinine > 1.3 × ULN; 3. Hemoglobin < 85.0 g/L in male subjects, < 80.0 g/L in female subjects; 4. White blood cell count (WBC) < 3.0 × 10^9/L; 5. Neutropenia (< 1.5 × 10^9/L); 6. Thrombocytopenia (platelets < 100 × 10^9/L); 12. Evidence of positive test results for hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or syphilis; 13. History of alcohol abuse or illicit drug abuse within one year prior to screening; 14. Subjects who are allergic to any components or excipients of the investigational drug used in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PASIscore;Inflammatory cytokines.;T lymphocyte subsets.; | — |
Countries
China
Contacts
Public ContactTu Ying
First Affiliated Hospital of Kunming Medical University
Outcome results
None listed