Clinical trial NCT06846255: Comparing DCP and DAP for Pemphigus Vulgaris
Official title: Comparison of Successful Treatment Outcomes of Dexamethasone Cyclophosphamide Pulse (DCP) Therapy and Dexamethasone Azathioprine Pulse (DAP) Therapy in Pemphigus Vulgaris Patients At a Tertiary Care Hospital, Karachi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pemphigus Vulgaris
Lead sponsor: Jinnah Postgraduate Medical Centre
Sponsor class: OTHER_GOV
First posted: 2025-02-26
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pemphigus Disease Area Index (PDAI)
timeFrame: Baseline, 3 months & 6 months
Secondary outcomes:
Other outcomes:
measure: Dermatology Life Quality Index
timeFrame: baseline, 3 months, 6 months
Locations:
city: Karachi
country: Pakistan
facility: Jinnah Postgraduate Medical Center
state: Sindh
Study officials:
affiliation: Jinnah Postgraduate Medical Centre
name: Zainab Javed, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Jinnah Postgraduate Medical Centre
name: Rabia Ghafoor, MBBS, FCPS
role: STUDY_CHAIR
References:
citation: Chryssomallis F, Dimitriades A, Chaidemenos GC, Panagiotides D, Karakatsanis G. Steroid-pulse therapy in pemphigus vulgaris long term follow-up. Int J Dermatol. 1995 Jun;34(6):438-42. doi: 10.1111/j.1365-4362.1995.tb04450.x.
citation: Fernandes NC, Menezes M. Pulse therapy in pemphigus: report of 11 cases. An Bras Dermatol. 2013 Jul-Aug;88(4):672-5. doi: 10.1590/abd1806-4841.20131840.
citation: Hassan I, Sameem F, Masood QM, Majid I, Abdullah Z, Ahmad QM. Non Comparative Study on Various Pulse Regimens (DCP, DAP and DMP) in Pemphigus: Our Experience. Indian J Dermatol. 2014 Jan;59(1):30-4. doi: 10.4103/0019-5154.123487.
citation: Mustafi S, Sinha R, Hore S, Sen S, Maity S, Ghosh P. Pulse therapy: Opening new vistas in treatment of pemphigus. J Family Med Prim Care. 2019 Mar;8(3):793-798. doi: 10.4103/jfmpc.jfmpc_114_19.