Primary cutaneous amyloidosis
Conditions
Interventions
Tofacitinib treated group:Tofacitinib Citrate 5mg BID
Sponsors
Dermatology Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1.No other skin diseases or systemic diseases were found to cause pruritus, and was diagnosed as primary cutaneous amyloidosis patient with NRS>=5. 2.The researchers believe that participants will benefit from participating in this clinical trial. 3.Have fully understood the clinical trial and voluntarily signed the informed consent. 4.The clinical trial of tofacitnib was completed for 12 weeks with good compliance. 5.Subjects agreed to use effective birth control throughout the research period (from screening to 6 months after the final dose).
Exclusion criteria
Exclusion criteria: 1.LYM 2ULN, TBIL > 1.5ULN, Cr > 1.5ULN. 3.CT examination indicated active pulmonary infection. 4.Tuberculosis infection, HIV (+), HBsAg (+) and HBV-DNA > 500IU/mL, HCV infection, Active syphilis. 5.Subjects with chronic active or acute infections require systemic treatment with antibiotics, antiviral, antiparasitic, antiprotozoal or antifungal agents. 6.A known or suspected history of immunosuppression, including a history of aggressive opportunistic infections (such as histoplasmosis, listeriosis, coccidioidosis, pneumosporosis and aspergillus), even after the infection has subsided; Or unusually frequent, recurrent, or long-term infections. 7.Subjects with malignant tumors in the previous 5 years before screening. 8.Women who were pregnant or nursing, or planned to become pregnant or nursing during the study period 9.The investigator estimates that there are any other subjects who are not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| numerical rating scale of pruritus;dermatology life quality index;Investigator's Global Assessment;routine blood test;blood biochemical examination;Coagulation function;Tumor markers; | — |
Countries
China
Contacts
Public ContactYang Bin
Dermatology Hospital of Southern Medical University
Outcome results
None listed