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CTRI Number  CTRI/2024/03/064871 [Registered on: 28/03/2024] Trial Registered Prospectively
Last Modified On: 15/03/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To evaluate the specific blood parameters in blistering skin disorders and compare it with the healthy population  
Scientific Title of Study   Assessment of immuno-metabolic axis of Autoimmune Blistering Diseases (AIBDs) – Mechanistic and diagnostic implications  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Raghavendra Rao 
Designation  Professor and Head of the Department 
Affiliation  Kasturba Medical College Manipal 
Address  Department of Dermatology Kasturba Medical College Madhav Nagar Manipal Udupi Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9845292640  
Fax    
Email  jenny.rao@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Raghavendra Rao 
Designation  Professor and Head of the Department 
Affiliation  Kasturba Medical College Manipal 
Address  Department of Dermatology Kasturba Medical College Madhav Nagar Manipal Udupi Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9845292640  
Fax    
Email  jenny.rao@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Raghavendra Rao 
Designation  Professor and Head of the Department 
Affiliation  Kasturba Medical College Manipal 
Address  Department of Dermatology Kasturba Medical College Madhav Nagar Manipal Udupi Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9845292640  
Fax    
Email  jenny.rao@manipal.edu  
 
Source of Monetary or Material Support  
Department of Dermatology Kasturba medical college Manipal 
Indian Association of Dermatologists Venereologists and Leprologists (IADVL) 
 
Primary Sponsor  
Name  Indian Association of Dermatologists Venereologists and Leprologists (IADVL) 
Address  314-315 3rd floor KM trade- tower H 3 sector 14 Kaushambi Ghaziabad Uttar Pradesh  
Type of Sponsor  Other [National association of Dermatologists] 
 
Details of Secondary Sponsor  
Name  Address 
Department of Dermatology Kasturba medical college Manipal  Department of Dermatology Kasturba medical college Madhav nagar Manipal Udupi 576104 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Raghavendra Rao  Kasturba Hospital Manipal  Department of Dermatology, Kasturba Hospital, Manipal
Udupi
KARNATAKA 		 9845292640

jenny.rao@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  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  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All new cases of Pemphigus (and its variants) and Pemphigoid group of diseases diagnosed by immunofluorescence studies(DIF/IIF) or serological methods. 
 
ExclusionCriteria 
Details  a. Patients unwilling to give consent for the study or investigations.
b. Patients who are in remission.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to study the difference between cytokine and metabolomic profiles of patients with autoimmune blistering disorders with that of control group  at first presentation to the principle investigator 
 
Secondary Outcome  
Outcome  TimePoints 
to study the difference between the cytokine & metabolomic profile of pemphigus & pemphigoid group of conditions  over a period of 2 years 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   01/04/2024 
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 Applicable 
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 - NO
Brief Summary  

Through this cross-sectional comparative study, we intend to compare the cytokine and metabolic profile of the pemphigus and pemphigoid group of patients with the control group. This study will be conducted over two years, with a sample size of 42 (21 in each group). 21 new cases of Pemphigus (and its variants) and Pemphigoid group of diseases, diagnosed by immunofluorescence studies (DIF/IIF) or serological methods, and consenting to participate in the study will be included in the case group. 21 age and sex-matched controls will also be recruited. Cytokine and metabolomic analysis will be carried out on all participants and the results obtained will be analyzed by statistical tools such as R, Mass Profiler Plus, and SPSS. All the analyzed data will be interpreted and reported. Thus by this study,  we intend to add information to the literature regarding the role of cytokine profile in these conditions, which may be helpful in the future for coming up with treatment modalities targeting this pathway.


 
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