Pemphigus
Conditions
Interventions
Glucocorticoid hormone group:This group receives systemic glucocorticoid , initially ,with prednisone at 1mg/kg/day. Then we adjust the dose of glucocorticoid according to the patients' responses.
Glucocorticoids joint methotrexate (MTX) group:This group receives systemic glucocorticoid plus MTX and starts with prednisone at 1mg/kg/day and MTX oral intake at 15mg/week. Then we adjust the dose o
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) Subjects 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/AST=1.5×upper limits of normal(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 score;Date of erosion surface completely drying;New vesicular stop time;Date of glucocorticoid starting to reduce;Glucocorticoid dosage; | — |
Secondary
| Measure | Time frame |
|---|---|
| Electrocardiogram;Chest X-ray/CT;Pemphigoid antibodies tite; | — |
Countries
China
Contacts
Public ContactBaoxi Wang
Institute of dermatology, Chinese Academyof Medical Sciences
Outcome results
None listed