Adult psoriasis vulgaris
Conditions
Interventions
Experimental group 1:TAF-001Cream
Control group:Placebo
Control group:Reference drug 1(Betamethasone Valerate Cream)
Control group:Reference drug 2(Benvitimod Cream)
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 years and above, no gender restrictions. 2. Patients clinically diagnosed with psoriasis vulgaris, with a confirmed diagnosis of at least 6 months by the screening period. 3. BSA of the trunk and/or extremities is 10-20% (excluding the head, palms, fingernails/toenails, soles of the feet, perianal and genital areas, and skin folds). 4. Baseline PGA score is 3. 5. For women of childbearing age with reproductive potential (including those who have had menarche and do not meet the criteria for no reproductive potential), a negative blood pregnancy test at the baseline screening and agreement to take effective contraceptive measures during the study period are required. Women without reproductive potential must meet at least one of the following criteria: a. Postmenopausal, defined as at least 12 consecutive months of amenorrhea without other pathological or physiological causes; d. Have undergone hysterectomy and/or bilateral oophorectomy, with documented records; c. Medically confirmed ovarian failure. 6. Fully understand the trial content, voluntarily participate in the trial, and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with non-plaque psoriasis (such as erythrodermic psoriasis, pustular psoriasis, psoriatic arthritis, guttate psoriasis) and inverse psoriasis. 2. Those known to have severe organ and system diseases, including cardiovascular and cerebrovascular systems (such as heart failure, unstable angina), kidneys (such as renal dysfunction), liver (such as liver cirrhosis), lungs (such as chronic obstructive pulmonary disease), endocrine systems (such as Cushing's syndrome, Addison's disease, parathyroid diseases), central nervous system, blood system or bone marrow and muscle system diseases. 3. Those with serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels more than twice the upper limit of normal, or serum creatinine levels more than 1.5 times the upper limit of normal. 4. Those with active human immunodeficiency virus (HIV) infection, active hepatitis C virus (HCV) infection (anti-HCV positive), active hepatitis B virus (HBV) infection (HBV-DNA > 2000 IU/mL or 10,000 copies/mL), or positive syphilis spirochete antibody. 5. Pregnant or lactating women, or women with plans to become pregnant. 6. Those known to be allergic to the active ingredients or excipients of the study drug. 7. Those with a history of alcohol abuse or drug abuse/dependence within 12 months prior to screening. 8. Those with other skin diseases or skin conditions in the treatment area that the investigator believes would interfere with the assessment of psoriasis, such as definite bacterial, viral, fungal, or parasitic skin infections, seborrheic dermatitis, atopic dermatitis, or the presence of pigmentation, large scars, pigmented lesions, sunburn, etc. 9. Those who have participated in any other drug clinical trials within 3 months prior to the first administration of the study drug. 10. A history of malignant cancer within the past 5 years or having received treatment for any type of malignant tumor (except for skin squamous cell carcinoma, basal cell carcinoma or skin carcinoma in situ that were cured only through cryosurgery or surgical excision). 11. Those who have received biologic agents known to affect psoriasis (such as secukinumab, adalimumab, infliximab, etc.) before the baseline visit and have not reached 5 half-lives of the drug after administration. 12. Those who have received ultraviolet phototherapy, photochemotherapy, excimer laser therapy or systemic treatments known to affect psoriasis (including systemic glucocorticoids, retinoids, immunosuppressants, phosphodiesterase 4 inhibitors, traditional Chinese medicine, etc.) within 4 weeks before the baseline visit. 13. Those who have received local treatments known to affect psoriasis (including topical glucocorticoids, vitamin D3 derivatives, retinoids, calcineurin inhibitors, aryl hydrocarbon receptor modulators, etc.) within 2 weeks before the baseline visit. 14. Subjects who may be unable to complete the study for other reasons or whom the investigator deems unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients achieving a 75% reduction in mPASI (mPASI 75 response rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of patients achieving clearance (0) or near clearance (1) on the PGA and showing a decrease of at least 2 points from baseline (PGA response rate);The percentage of patients achieving a 90% reduction in mPASI (mPASI 90 response rate);The percentage change in mPASI from baseline;Percentage change in BSA from baseline;The longitudinal change value of mPASI score;The longitudinal change value of PGA score; | — |
Countries
China
Contacts
Public ContactJianzhong Zhang; Cheng Zhou
Peking University People's Hospital
Outcome results
None listed