Pemphigus
Conditions
Interventions
Glucocorticoid group:This group receives systemic glucocorticoid, initially, with prednisone at 1mg/kg/day.
Sponsors
Institute of dermatology, Chinese Academyof Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) 18 to 75 years old, male or female; (2) Meet the diagnostic criteria for pemphigus(erythema and vesicles on skins and/or mucous membranes; dermatopathology shows bulla above the basal cell layer; direct or indirect immunofluorescence (DIF/IIF) staining reveals IgG and/or C3 deposited as reticular-pattern in the intercellular substance of the epidermis); (3) Skin lesion scores of Pemphigus Disease Area Index(PDAI) are between 30 to 90 points(scoring criteria refers to Appendix 11); (4) Patients completely understand the trial and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Regimen or dose of treatment for pemphigus have changed within one month; (2) Esophagus involved; (3) Subjects who have severe local or systemic acute or chronic infection which is difficult to control and may affect the efficacy of the drugs or the clinical evaluation; (4) Subjects who have severe heart, lung, liver (ALT=1.5×ULN), kidney or other severe diseases; (5) Pregnant and lactating female or subjects who have fertility plan recently; (6) With a history of malignant tumor; (7) Subjects who are allergic to the test drugs or have contraindications; (8) With other skin diseases that may affect the clinical evaluation; (9) Other conditions which researchers consider the subjects not compatible to the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PDAI;Date of stopping blisterring;Date of erosion surface completely drying;Date of glucocorticoid starting to reduce;Glucocorticoid dosage; | — |
Secondary
| Measure | Time frame |
|---|---|
| Electrocardiogram;CTChest X-ray/C; | — |
Countries
China
Contacts
Public ContactBaoxi Wang
Institute of dermatology, Chinese Academyof Medical Sciences
Outcome results
None listed