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CTRI Number  CTRI/2024/05/068041 [Registered on: 29/05/2024] Trial Registered Prospectively
Last Modified On: 28/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   How long can be the skin biopsy slides stored in room temperature without fading. 
Scientific Title of Study   Reliability of longterm preservation of immunofluorescence slides: a prospective observational study 
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 Swetha S Iyer 
Designation  Junior Resident 
Affiliation  Kasturba Medical College Manipal 
Address  Room No.21 Department of dermatology old OPD block skin OPD Kasturba Medical hospital manipal

Udupi
KARNATAKA
576104
India 
Phone  7397317766  
Fax    
Email  iyerswetha98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Raghavendra Rao 
Designation  PROFESSOR AND HOU 
Affiliation  Kasturba Medical College Manipal 
Address  Room No.21 Department of Dermatology old OPD block skin OPD Kasturba Medical hospital manipal

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 HOU 
Affiliation  Kasturba Medical College Manipal 
Address  Room No.21 Department of Dermatology old OPD block skin OPD Kasturba Medical hospital manipal

Udupi
KARNATAKA
576104
India 
Phone  9845292640  
Fax    
Email  jenny.rao@manipal.edu  
 
Source of Monetary or Material Support  
Thesis Research Grant Kasturba Medical college Madhav Nagar Manipal pin code 576104 
 
Primary Sponsor  
Name  Kasturba medical college hospital 
Address  Kasturba Medical College Hospital Madhav Nagar Manipal pin code 576104 
Type of Sponsor  Private medical college 
 
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 
Dr Swetha S Iyer  Kasturba Hospital Manipal  Room No.21 department of dermatology old OPD Block skin OPD Kasturba hospital Manipal
Udupi
KARNATAKA 		 7397317766

iyerswetha98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L100||Pemphigus vulgaris, (2) ICD-10 Condition: L102||Pemphigus foliaceous, (3) ICD-10 Condition: L120||Bullous pemphigoid, (4) ICD-10 Condition: L128||Other pemphigoid, (5) ICD-10 Condition: L930||Discoid lupus erythematosus, (6) ICD-10 Condition: L130||Dermatitis herpetiformis, (7) ICD-10 Condition: L138||Other specified bullous disorders, (8) ICD-10 Condition: L14||Bullous disorders in diseases classified elsewhere, (9) ICD-10 Condition: L139||Bullous disorder, unspecified, (10) ICD-10 Condition: L950||Livedoid vasculitis, (11) ICD-10 Condition: L958||Other vasculitis limited to the skin, (12) ICD-10 Condition: L123||Acquired epidermolysis bullosa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All DIF positive slides that is reported in the DIF lab. 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Recording the intensity of the direct immunofluorescence slides in baseline and subsequent months and analyzing the data and calculating the survival of slides in percentage  Detection of tissue bound immune reactants by direct immunofluorescence microscopy at 3rd 6th 12th months.  
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare the intensity of staining at baseline and at subsequent reading.
2.To compare the positivity at different temperature settings.
 		 Detection of tissue bound immune reactants by direct immunofluorescence microscopy at 3rd 6th 12th months.  
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
Final Enrollment numbers achieved (Total)= "240"
Final Enrollment numbers achieved (India)="240" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2024 
Date of Study Completion (India) 01/01/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
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  

Direct immunofluorescence has proven indispensable in the examination and identification of diverse immuno bullous diseases. Despite its widespread application, there is limited understanding of how well the fluorescent staining, particularly in skin specimens, can be preserved.Reviewing DIF slides can be important for re-evaluating a previously rendered diagnosis, either for an internal review or an outside consultation. Thus a reliable storage period for keeping  IF slides, should be well established. 

Out of 240 slides 80 are stored in deep freezers as controls, 80 in room temperature and 80 in cool temperature (22 degree C) in light proof packets and examined subsequently by dermatologist who was blind to initial diagnosis at 3rd , 6th and 12th  months.

 
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