Skip to content

The effect of pulse therapy in pemphigus patients

Randomized controlled trial to evaluate the effect of dexamethasone/ dexamethasone-cyclophosphamide pulse therapy on lymphocytes subpopulation in pemphigus vulgaris: a pilot study - Not required

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/03/008270
Enrollment
50
Registered
2017-03-30
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Pemphigus vulgaris

Interventions

Intervention1: Dexamethasone cyclophosphamide pulse theapy: Infusion of 100 mg dexamethasone in 500 ml of 5% glucose will be given daily for three consecutive days, with 500mg cyclophosphamide infusio

Sponsors

Department of Science Technology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subject of either sex, aged 18-70 years presenting with vesiculobullous lesions on skin and/or oral erosions showing either - Histological features of suprabasal acantholysis and / or - Positive desmoglein 3 and/or desmoglein 1 levels 2. Pemphigus vulgaris of moderate to severe involvement (BSA >= 5%)

Exclusion criteria

Exclusion criteria: 1. Age 70 years 2. Unmarried individuals or those who have not completed family. 3. Pregnant or lactating women. 4. Patients with severe cardiac, renal or hepatic disease. 5. Autoimmune blistering disease other than PV. 6. Active, unhealed peptic ulcer within 3 months prior to randomization. 7. Inherited or acquired immune deficiency 8. Malignancy, lymphoproliferative diseases or previous total lymphoid irradiation. 9. Chronic or frequent drug resistant, bacterial infections or presence of severe active infection. 10. Bone marrow insufficiency. 11. Frequent and / or serious viral infections. 12. Systemic or invasive fungal disease within 2 years prior to randomization.

Design outcomes

Primary

MeasureTime frame
Change in the levels of lymphocyte subpopulation in pemphigus after dexamethasone cyclophosphamide therapy and dexamethasone pulse therapy. Timepoint: 1st, 2nd, 4th week, 3rd month and 6th month

Secondary

MeasureTime frame
Correlation of disease activity in these patients with changes in these immunological parameters. Timepoint: 1st, 2nd, 4th week, 3rd month and 6th month

Countries

India

Contacts

Public ContactDr Neetu Bhari

All India Institute of Medical Science

drntbhari@gmail.com09650437049

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026