Pemphigus Vulgaris
Conditions
Brief summary
What's the study about? This study focused on comparing two different treatments for pemphigus vulgaris, a skin condition caused when body's immune system works against itself. The treatments were dexamethasone cyclophosphamide pulse (DCP) therapy and dexamethasone azathioprine pulse (DAP) therapy. Why was this study done? The goal of the study was to determine which treatment, DCP or DAP, was more effective in treating pemphigus vulgaris. Both treatments involve high-dose steroids combined with other medications, but they differ in the specific medications used. How did they do the study? Researchers conducted a randomized controlled trial, where patients were randomly assigned to receive either DCP or DAP therapy. They then followed these patients to see how well each treatment worked.
Detailed description
Consenting patients presenting with pemphigus vulgaris visiting Outpatient Department of Dermatology, Jinnah Postgraduate Medical Centre, Karachi, were enrolled in this study who fulfilled the inclusion criteria. Permission from the institutional ethical review committee were taken prior to conduction of study. Brief history was taken about the duration of pemphigus vulgaris, demographic data (age, gender and residence status) and written informed consent in local language (Urdu) was taken from each patient. Patients were randomly allocated using sealed opaque envelop bearing A= Dexamethasone cyclophosphamide pulse (DCP) therapy and B= and dexamethasone azathioprine pulse (DAP) therapy. Patients in group A received monthly doses of 100 mg of dexamethasone dissolved in 500 ml of 5% dextrose by slow intravenous infusion over 2 h on 3 consecutive days along with 500 mg of cyclophosphamide in the infusion on day 2. In between the pulses, patients received 50 mg of oral cyclophosphamide daily. Patients in group B, cyclophosphamide bolus dose on day 2 omitted, and a daily dose of 50 mg of azathioprine will be given throughout the pulses. Patient's blood pressure, pulse rate, heart rate was monitored every 15 min during the period of infusion. Serum electrolytes and electrocardiography was repeated after completion of each pulse. The cycles was repeated at 28-day interval starting from day 1 of the previous cycle. Response to both treatment regimens was evaluated after 3 cycle and successful treatment outcome was labeled as per operational definition. The findings of quantitative variable (age, mean PDAI score in group A and B, and duration of pemphigus vulgaris) and qualitative variables (gender, residence status, smoking status, family monthly income, occupational status and successful treatment outcome) was entered in a form. Data was analyzed on Statistical Package for the Social Sciences software Version 22.
Interventions
DRUGDexamethasone Cyclophosphamide Pulse therapy
33 patients were enrolled in DCP group. They were given Dexamethasone Cyclophosphamide pulse therapy for 6 months and successful treatment outcome was assessed using Pemphigus Disease Area Index (PDAI) scores.
DRUGDexamethasone Azathioprine Pulse therapy
33 patients were enrolled in DAP group. They were given Dexamethasone Azathioprine pulse therapy for 6 months and successful treatment outcome was assessed using Pemphigus Disease Area Index (PDAI) scores.
Sponsors
Jinnah Postgraduate Medical Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients with Pemphigus Vulgaris for more than one month * Either gender * Pemphigus Disease Area Index (PDAI) ≥ 15 points * Age 20-60 years
Exclusion criteria
* History of Hepatitis C, B, or HIV infection * History of connective tissue disorders, malignancy, diabetes mellitus, hypo/hyperthyroidism * Pregnant patients * History of congestive cardiac failure, chronic liver disease, asthma, chronic obstructive pulmonary disease and stroke
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pemphigus Disease Area Index (PDAI) | Baseline, 3 months & 6 months | Successful treatment outcome is assessed with Pemphigus Disease Area Index (PDAI) score. Lower score means better outcome |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dermatology Life Quality Index | baseline, 3 months, 6 months | Life quality of patients enrolled was assessed during study using Dermatology Life Quality Index (DLQI). Higher score means negative impact on patient's quality of life |
Countries
Pakistan
Outcome results
None listed