Pemphigus Vulgaris. Pemphigus vulgaris
Conditions
Interventions
Intervention group: Treatment with Apremilast is done as an add-on to prednisolone. On the first day, the treatment starts with a dose of 10 mg, and every day 10 mg is added to it until the sixth day.
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Definite diagnosis of Pemphigus Vulgaris based on clinical findings, histopathology and immunofluorescence. New or known case having persistent lesions in spite of treatment. Having persistent lesion based on definition : the presence of persistent or slow-healing lesions during prednisolone tapering in the absence of new lesions while receiving more than minimal therapy. Dose of prednisolone must be a fixed dose of less than 20 mg per day for at least one month . It must have been three months since the last dose of Rituximab .
Exclusion criteria
Exclusion criteria: Pregnancy or breastfeeding. Uncontrolled systemic disease. Taking drugs that have interaction with Apremilast . History of depression , suicidal idea/act or taking anti-depression drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Level of antibody against Desmoglein 1 and Desmoglein 3. Timepoint: At the beginning of the study and 4 months after taking Apermilast . Method of measurement: Measuring the level of antibodies in the blood .;Disease severity based on the PDAI (Pemphigus disease area index) scoring system . Timepoint: At the beginning of the study and 4 months after taking Apermilast . Method of measurement: PDAI (Pemphigus disease area index) scoring form .;Patients satisfaction with treatment. Timepoint: At the beginning of the study and 4 months after taking Apermilast . Method of measurement: TABQOL (Treatment of Autoimmune Bullous Disease Quality of Life ) questionnaire .;Size of the lesions. Timepoint: At the beginning of the study and 4 months after taking Apermilast . Method of measurement: Measuring the largest diameter of the lesion with a ruler. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactShabnam Ramezanpour
Tehran University of Medical Sciences
Outcome results
None listed