pemphigus vulgaris. Pemphigus vulgaris
Conditions
Interventions
Intervention 1: Control group will receive azathioprine 2.5 mg/kg and prednisolone 1 mg/kg every day with gradual tapering of steroid during the follow up period. Intervention 2: Intervention group wi
Treatment - Drugs
Control group will receive azathioprine 2.5 mg/kg and prednisolone 1 mg/kg every day with gradual tapering of steroid during the follow up period.
Intervention group will receive tacrolimus 0.03 mg/ kg and prednisolone 1 mg/kg with gradual tapering of steroid during the follow up.
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 46 patients from 20 to 80 years old; new pemphigus vulgaris or new disease activity; the clinical diagnosis of pemphigus vulgaris will be based on clinical presentation and histological analysis (+/- immunofluorescences study) of at least 1 biopsy specimen from the skin or the mucosa. Exclusion criteria: Having contraindications for the use of azathioprine, tacrolimus or prednisolone; any history of hypersensitivity to these drugs; active infection; pregnancy; lactation or no ability to attend follow-up; severe side effect during the study period.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Arrest of disease progression. Timepoint: 2 months. Method of measurement: arrest of new bulla fromation, 70% re-epithelization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Remission of the disease. Timepoint: 6-8 months. Method of measurement: no new bulla and no disease activity. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaryam Sadati
Shiraz University of Medical Sciences
Outcome results
None listed