A Phase 4 interventional study of Dexamethasone Cyclophosphamide Pulse therapy and Dexamethasone Azathioprine Pulse therapy in Pemphigus Vulgaris, sponsored by Jinnah Postgraduate Medical Centre. Completed at 1 site in Pakistan. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-02-28.
Sponsored by Jinnah Postgraduate Medical Centre · Phase 4, Interventional, and Treatment
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.
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.
76 studies on the registry are indexed under Pemphigus; 18 are open to participants now.
This study's enrollment of 66 is above the median of 30 across 53 interventional studies indexed under Pemphigus.
Browse Pemphigus studies →Jinnah Postgraduate Medical Centre is the lead sponsor of 38 studies on the registry; 14 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients were randomly assigned to two groups. The DCP group received therapy consisting of monthly doses of 100 mg dexamethasone dissolved in 500 ml of 5% dextrose, administered intravenously over 2 hours on 3 consecutive days. On the second day, 500 mg of cyclophosphamide was added in infusion. Between treatment cycles, patients took 50 mg of cyclophosphamide orally each day. This treatment regimen continued for 6 months, and outcomes were assessed after 3 treatment cycles.
Drug: Dexamethasone Cyclophosphamide Pulse therapy
Patients were randomly assigned to two groups. The DAP group received therapy consisting of monthly doses of 100 mg dexamethasone dissolved in 500 ml of 5% dextrose, administered intravenously over 2 hours on 3 consecutive days. Cyclophosphamide is replaced by daily oral azathioprine. No bolus dose of azathioprine is given. This treatment regimen continued for 6 months, and outcomes were assessed after 3 treatment cycles.
Drug: Dexamethasone Azathioprine 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.
Also known as: Injection Decadron, Cytoxan 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.
Also known as: Injection Decadron , Tablet Imuran Pulse therapy
Pemphigus Disease Area Index (PDAI)
Successful treatment outcome is assessed with Pemphigus Disease Area Index (PDAI) score. Lower score means better outcome
Time frame: Baseline, 3 months & 6 months
Dermatology Life Quality Index
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
Time frame: baseline, 3 months, 6 months
Plan to share: No
Ran from Jun 2021 to primary completion in Dec 2021, 6 months.
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Jinnah Postgraduate Medical Centre