Chronic Psoriasis Vulgaris
Conditions
Interventions
single arm:Tazarotene and Betamethasone Dipropionate Cream (once daily)
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
17 Years to 72 Years
Inclusion criteria
Inclusion criteria: (1) Patients clinically diagnosed with chronic plaque psoriasis; (2) Psoriasis affecting <20% of the body surface area; (3) Aged between 18 to 65 years, either sex; (4) Subjects having understood and signed a written informed consent form prior to any study related procedures being carried out.
Exclusion criteria
Exclusion criteria: (1) Those who are allergic to any one of the vitamin A acid drugs and the research drug; (2) Subjects with drip-type, erythrodermic, pustular, and arthritic psoriasis; or other dermatological subjects who may interfere with the assessment of the disease condition; and whose skin lesions with severe skin damage and infection. (3) Subjects suffering from severe organ and systemic diseases, including cardiovascular (such as heart failure, unstable angina), liver (such as cirrhosis), kidney (such as renal failure), lung (such as chronic obstructive pulmonary disease), endocrine (such as Cushing syndrome), nervous system and blood system diseases, and other autoimmune diseases, malignant tumors or other diseases that investigators believe are not suitable for the study; (4) The laboratory test results showed any of the following abnormalities: peripheral blood leukocyte count 15x10^9/L; hemoglobin2 times the upper limit of normal value; serum creatinine, BUN>1.5 times the upper limit of normal value; triglyceride or total cholesterol>3 times the upper limit of normal value; positive blood pregnancy test for women of childbearing age; (5) Subjects who received topical treatment of psoriasis drugs (glucocorticoids, vitamin D3 derivatives, retinoic acid and calcineurin inhibitors) within 2 weeks before screening; phototherapy (UVA, UVB) within 4 weeks; systemic drugs (retinoic acid, MTX, cyclosporine, glucocorticoids and traditional Chinese medicine) within 4 weeks; treated with IL~12/IL~23 inhibitor within 6 months; 3 months Intravenous treatment with TNF antagonists; (6) Those who participated in other clinical research within the first 3 months of this study; (7) Pregnant and lactating women, or women who are ready to conceive during the study; (8) Conditions that may affect subject compliance, such as long-term travel or vacation, drug use, drug addiction, and mental illness; (9) Subjects investigator believes is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall adverse reaction rate after 4 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of adverse events associated with glucocorticoids after 4 weeks of treatment;Proportion of subjects who achieved a PASI of 50, 75, and 90 response after 4 weeks of treatment;Decline rate of PASI score relative to baseline after 4 weeks of treatment;Proportion of “successful treatment” for the overall assessment of PGA after 4 weeks of treatment;DLQI;Recurrence rate;The incidence of overall adverse reactions, the incidence of adverse reactions associated with glucocorticoids, the proportion of subjects achieving PASI 50, 75, 90 responses, the rate of decline in PASI scores relative to relapse, PGA, DLQI, of patients cured basically after 4 weeks of re-medication; | — |
Countries
China
Contacts
Public ContactJIN HONGZHONG
Peking Union Medical College Hospital (Dongdan Campus)
Outcome results
None listed