Comparing DCP and DAP for Pemphigus Vulgaris

Phase 4

Completed

• Conditions: Pemphigus Vulgaris
• Interventions: Drug: Dexamethasone Cyclophosphamide Pulse therapy; Drug: Dexamethasone Azathioprine Pulse therapy

• Registration Number: NCT06846255
• Lead Sponsor: Jinnah Postgraduate Medical Centre

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.

Study Timeline

• Study Start: 2021-06-15
• Primary Completion: 2021-12-15
• Study Completion: 2021-12-15
• Status Verified: 2025-02
• Study First Submitted: 2025-02-24
• Study First Submitted QC: 2025-02-24
• Last Update Submitted: 2025-02-25
• Study First Posted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone Cyclophosphamide Pulse therapy group (DCP group)	Dexamethasone Cyclophosphamide Pulse therapy	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.
Dexamethasone Azathioprine Pulse therapy group (DAP group)	Dexamethasone Azathioprine 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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Jinnah Postgraduate Medical Center; 🇵🇰 Karachi, Sindh, Pakistan