Comparing DCP and DAP for Pemphigus Vulgaris

NCT06846255 | Completed Phase 4

• 1 other identifier: 53727
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Pemphigus Vulgaris

Outcome Measures

Primary Outcomes (1)

• Pemphigus Disease Area Index (PDAI)

  Successful treatment outcome is assessed with Pemphigus Disease Area Index (PDAI) score. Lower score means better outcome

  Baseline, 3 months & 6 months

Other Outcomes (1)

• Dermatology Life Quality Index

  baseline, 3 months, 6 months

Study Arms (2)

Dexamethasone Cyclophosphamide Pulse therapy group (DCP group)

ACTIVE COMPARATOR

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

Dexamethasone Azathioprine Pulse therapy group (DAP group)

ACTIVE COMPARATOR

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

Interventions

Dexamethasone Cyclophosphamide Pulse therapy DRUG

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

Dexamethasone Cyclophosphamide Pulse therapy group (DCP group)

Dexamethasone Azathioprine Pulse therapy DRUG

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

Dexamethasone Azathioprine Pulse therapy group (DAP group)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with Pemphigus Vulgaris for more than one month
• Either gender
• Pemphigus Disease Area Index (PDAI) ≥ 15 points
• Age 20-60 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Jinnah Postgraduate Medical Centre: lead

Study Sites (1)

Jinnah Postgraduate Medical Center

Karachi, Sindh, 75510, Pakistan

Location

Related Publications (4)

• 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.

  PMID: 7657447 BACKGROUND

• 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.

  PMID: 24068153 BACKGROUND

• 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.

  PMID: 24470657 BACKGROUND

• 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.

  PMID: 31041203 BACKGROUND

MeSH Terms

Conditions

Pemphigus

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Zainab Javed, MBBS

  Jinnah Postgraduate Medical Centre

  PRINCIPAL INVESTIGATOR

• Rabia Ghafoor, MBBS, FCPS

  Jinnah Postgraduate Medical Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 26, 2025
• Study Start: June 15, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)