pemphigus vulgaris. Pemphigus vulgaris
Conditions
Interventions
Intervention group: for 15 patient with mucocutaneous recalcitrant lesion of pemphigus vulgaris , we will prescribe intralesional injection of rituximab with dose of 5 mg/cm2 ( 0/5 cc per 1 cm2 of l
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: suffering from pemphigus vulrais, confirmed by clinical, histoligical and immunological criteria. Skin or mucosal lesions with maximum diameter of 6 cm or 20 cm2 which are recalcitrant (means continued development of new lesions, continued extension of old lesions, or failure of established lesions to begin to heal despite 3 weeks of therapy on 1.5 mg/kg/d of prednisone equivalent with or without any of the following agents: cyclophosphamide 2 mg/kg/d for 12 weeks; azathioprine 2.5 mg/kg/d for12 weeks (if thiopurine s-methyltransferase level is normal); methotrexate 20 mg/wk for 12 weeks; or mycophenolate mofetil 3 g/d for 12 weeks.). Insufficient response to three times intralesional injection of triamcinolone acetonide or topical super potent corticosteroid for at least 1 month. no new lesion in recent 12 weeks. no cardiac or infectious contraindication to rituximab. oral steroid usage of <= 20 mg/d.
Exclusion criteria
Exclusion criteria: Patients with active lesions (expansion of previous old lesions or new lesions in recent 12 weeks). Contraindications to rituximab (including hepatitis B, hepatitis C, progressive neurologic disease, angina, arrhythmia, herpes virus infection, CMV infection, acute pneumonia, renal diseases, lactation, hyperphosphatemia, hypocalcemia, hyperkalemia, anemia, low platelet or leukocyte count. Injection of intravenous rituximab in recent 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti desmogline 1. Timepoint: baseline , 3 months , 6 months later. Method of measurement: blood sampling.;Anti desmogline 3. Timepoint: baseline , 3 months , 6 months. Method of measurement: blood sampling.;CD4 cell count. Timepoint: baseline , 15 day and 1 month later. Method of measurement: blood sampling.;CD19 cell count. Timepoint: baseline , 15 day and 1 month later. Method of measurement: blood sampling. | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease severity. Timepoint: before intervention and 1, 3, 6 months after intervention. Method of measurement: Pemphigus Disease Area Index (PDAI ).;Patient satisfaction. Timepoint: baseline, 1 month , 3 month , 6 month later. Method of measurement: Visual analyze scale.;Quality of life. Timepoint: baseline, 1 month , 3 month , 6 month later. Method of measurement: pemphigus quality of life questioner.;Size of lesion. Timepoint: baseline, 15 days , 1 month , 3 month , 6 month later. Method of measurement: ruler. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactEBRAHIM MAZLOOM
Tehran University of Medical Sciences
Outcome results
None listed