Pemphigus VulgarisPhase 4DCP;DAPNCT06846255
Comparing DCP and DAP for Pemphigus Vulgaris
A Phase 4 study testing Dexamethasone Cyclophosphamide Pulse therapy and Dexamethasone Azathioprine Pulse therapy in people with Pemphigus Vulgaris, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Pemphigus Vulgaris
- What is being tested?
- Dexamethasone Cyclophosphamide Pulse therapy and Dexamethasone Azathioprine Pulse therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2021to 15 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with Pemphigus Vulgaris for more than one month
- Either gender
- Pemphigus Disease Area Index (PDAI) ≥ 15 points
- Age 20-60 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Pemphigus Vulgaris
- Being tested
- Dexamethasone Cyclophosphamide Pulse therapy, Dexamethasone Azathioprine Pulse therapy
- Medical subject headings
- Pemphigus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Cyclophosphamide Pulse therapyDrug
Also called Injection Decadron, Cytoxan 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.
Dexamethasone Azathioprine Pulse therapyDrug
Also called Injection Decadron , Tablet Imuran 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Dexamethasone Azathioprine Pulse therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pemphigus Disease Area Index (PDAI)
Successful treatment outcome is assessed with Pemphigus Disease Area Index (PDAI) score. Lower score means better outcome
Measured: Baseline, 3 months & 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start15 Jun 2021
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pemphigus VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinnah Postgraduate Medical Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zainab Javed, Jinnah Postgraduate Medical Centre
- Investigators
- Zainab Javed, MBBS, Principal investigator, Jinnah Postgraduate Medical CentreRabia Ghafoor, MBBS, FCPS, Study chair, Jinnah Postgraduate Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846255
- Sponsor's protocol ID
- 53727
- Acronym
- DCP;DAP
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 7657447Fernandes 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.
PubMed 24068153Hassan 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.
PubMed 24470657Mustafi 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.
PubMed 31041203
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06846255
- Acronym / sponsor ID
- DCP;DAP / 53727
- Conditions
- Pemphigus Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Jinnah Postgraduate Medical CentreOther government
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone Cyclophosphamide Pulse therapy group (DCP group) | Active comparator | Drug: Dexamethasone Cyclophosphamide Pulse therapyPatients 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) | Active comparator | Drug: Dexamethasone Azathioprine Pulse therapyPatients 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with Pemphigus Vulgaris for more than one month
- Either gender
- Pemphigus Disease Area Index (PDAI) ≥ 15 points
- Age 20-60 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone Cyclophosphamide Pulse therapyAlso: Injection Decadron, Cytoxan pulse therapy33 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. | Drug | Dexamethasone Cyclophosphamide Pulse therapy group (DCP group) |
| Dexamethasone Azathioprine Pulse therapyAlso: Injection Decadron , Tablet Imuran Pulse therapy33 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. | Drug | Dexamethasone Azathioprine Pulse therapy group (DAP group) |
Primary outcome
Pemphigus Disease Area Index (PDAI)
Time frame: Baseline, 3 months & 6 months
Successful treatment outcome is assessed with Pemphigus Disease Area Index (PDAI) score. Lower score means better outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Background: PubMed 7657447Chryssomallis 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.
- Background: PubMed 24068153Fernandes 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.
- Background: PubMed 24470657Hassan 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.
- Background: PubMed 31041203Mustafi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zainab Javed, MBBS principal investigator
Jinnah Postgraduate Medical Centre
Rabia Ghafoor, MBBS, FCPS study chair
Jinnah Postgraduate Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone Cyclophosphamide Pulse therapy and Dexamethasone Azathioprine Pulse therapy in people with Pemphigus Vulgaris, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pemphigus Disease Area Index (PDAI) (time frame: Baseline, 3 months & 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06846255, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.