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CTRI Number  CTRI/2025/08/092939 [Registered on: 12/08/2025] Trial Registered Prospectively
Last Modified On: 09/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare two steroid tapering schedules in pemphigus vulgaris 
Scientific Title of Study   Randomised Controlled trial to determine most appropriate prednisolone tapering protocol in management of pemphigus vulgaris 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dipankar De 
Designation  Professor 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Department of Dermatology, Venereology and Leprology, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9316123724  
Fax    
Email  dr_dipankar_de@yahoo.in  
 
Details of Contact Person
Scientific Query  
Name  Dipankar De 
Designation  Professor 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Department of Dermatology, Venereology and Leprology, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9316123724  
Fax    
Email  dr_dipankar_de@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Dipankar De 
Designation  Professor 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Department of Dermatology, Venereology and Leprology, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9316123724  
Fax    
Email  dr_dipankar_de@yahoo.in  
 
Source of Monetary or Material Support  
Postgraduate Institute of Medical Education and Research, Chandigarh 
 
Primary Sponsor  
Name  NIL 
Address  not applicable 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dipankar De  Postgraduate Institute of Medical Education and Research  Room number 5007, 5th floor, New OPD, PGIMER
Chandigarh
CHANDIGARH 		 9316123724

dr_dipankar_de@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Intramural)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L100||Pemphigus vulgaris,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Prednisolone tapering starting at the end of the consolidation phase  Participants in this group will receive oral prednisolone at a starting dose of: 0.5 mg/kg/day for mild pemphigus vulgaris (PV) 0.75 mg/kg/day for moderate PV They will also receive either azathioprine (1.5 mg/kg/day) or rituximab (1 g IV, 2 doses 2 weeks apart). Prednisolone tapering will be initiated at the end of the consolidation phase, defined as: no new lesions for at least 2 weeks and ~80% healing of existing lesions. The tapering will follow a standard weekly reduction schedule (from 60 mg down to 2.5 mg over 14 weeks). All participants will receive calcium (1000 mg/day) and vitamin D (500 IU/day) supplementation. If osteoporosis is detected, they will receive intravenous zoledronic acid (5 mg/100 ml). 
Comparator Agent  Prednisolone tapering starting at the time of disease control  Participants in this group will receive oral prednisolone at a starting dose of: 0.5 mg/kg/day for mild PV 0.75 mg/kg/day for moderate PV They will also receive either azathioprine (1.5 mg/kg/day) or rituximab (1 g IV, 2 doses 2 weeks apart). Prednisolone tapering will be initiated at the time of disease control, defined as: cessation of new lesion formation and initiation of healing of existing lesions. The same tapering schedule as the intervention group will be followed. Participants will also receive calcium and vitamin D supplementation, and if osteoporosis is detected, zoledronic acid will be administered. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Adult patients with pemphigus vulgaris
2. Treatment naïve or within 4 weeks of starting oral corticosteroid therapy
3. Mild to moderate disease
 
 
ExclusionCriteria 
Details  Patient not giving consent; Contraindication to oral steroids, rituximab or azathioprine; diagnosed case of osteoporosis (T score less than 2.5 on dexa scan); comorbidity or other treatment that affect bone health such as renal failure, hyperparathyroidism, chronic use of medications that affect bone health; pregnant and lactating women 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the incidence of steroid-induced osteoporosis between the two groups using BMD assessed by DEXA scan and to compare the rate of remission of pemphigus vulgaris   To compare the incidence of steroid-induced osteoporosis between the two groups using BMD assessed by DEXA scan at 0, 6 and 12 months and to compare the rate of remission of pemphigus vulgaris at 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the biochemical markers of bone turnover (serum calcium, phosphorus, albumin, ALP, vitamin D3, PTH,CTX1 and P1NP) between the two groups.  0, 3, 6 and 12 months 
To compare the time to achieve clinical remission on minimal therapy, and off therapy between the two groups  at 12 months 
To compare the rate of relapse of disease in those who achieved remission between the two groups.  at 12 months 
To compare the total cumulative steroid dose administered for the current disease episode before and after initiation of tapering between the two groups.  at 12 months 
To assess the quality of life of patients using the Autoimmune Bullous Disease Quality of Life (ABQOL) and Pemphigus Oral Lesions Intensity Score (POLIS).  At baseline and 12 months 
6. To compare the rate of disease flare in those who achieved disease control, between the two groups.  At 12 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr_dipankar_de@yahoo.in].

  6. For how long will this data be available start date provided 01-04-2027 and end date provided 31-12-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Pemphigus vulgaris (PV) is a chronic autoimmune blistering disease treated primarily with systemic corticosteroids. While effective, prolonged steroid use is associated with significant adverse effects, most notably osteoporosis. Current clinical guidelines lack robust evidence on the safest and most effective tapering strategies. This study aims to compare two commonly used tapering approaches: tapering of prednisolone at the time of disease control vs. at the end of the consolidation phase, to determine their impact on bone health and disease remission.

This is a single-centre, prospective, randomized, open-label, controlled trial involving 40 treatment-naïve (or recently initiated) adult patients with mild to moderate PV. Participants will be randomized 1:1 into two groups using computer-generated permuted block randomization with variable block sizes. Both groups will receive standard therapy with oral prednisolone and either azathioprine or rituximab. The primary outcomes are the incidence of osteoporosis (assessed by DEXA at 0, 6, and 12 months) and pemphigus remission rate at 12 months. Secondary outcomes include biochemical markers of bone turnover, quality of life assessments (ABQOL, POLIS), time to remission, disease flare/relapse rates, and cumulative steroid dose.

Due to the nature of the intervention, blinding of participants and treating physicians is not feasible, but outcome assessors will be blinded. The findings are expected to inform evidence-based tapering strategies that minimize steroid-induced complications while maintaining disease control in PV.

 
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