FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/083595 [Registered on: 27/03/2025] Trial Registered Prospectively
Last Modified On: 28/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assessment and comparison of social acceptance, body image, self esteem and quality of life in patients with facial vitiligo versus facial melasma-A comparative cross sectional study  
Scientific Title of Study   Assessment of social acceptance, body image, self esteem and quality of life in patients with facial vitiligo versus melasma- A comparative cross sectional 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 Biswajit Panda 
Designation  POST GRADUATE RESIDENT 
Affiliation  IMS & SUM HOSPITAL, BBSR, ODISHA 
Address  IMS AND SUM HOSPITAL, BHUBANESWAR ,Department of Dermatology ,Odisha

Khordha
ORISSA
751029
India 
Phone  08984431027  
Fax    
Email  biswajitdon3@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bikash Ranjan Kar 
Designation  Head of the Department and Professor of DVL  
Affiliation  Guide 
Address  Institute of Medical Sciences and Sum Hospital, Kalinga Nagar ,Department of Dermatology Ground floor, BHUBANESWAR

Khordha
ORISSA
751003
India 
Phone  9937428181  
Fax    
Email  bikashkar@soa.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Bikash Ranjan Kar 
Designation  Head of the Department and Professor of Dermatology 
Affiliation  Guide 
Address  Institute of Medical Sciences and Sum Hospital, Kalinga Nagar ,DEPARTMENT OF DERMATOLOGY,GROUND FLOOR, BHUBANESWAR, ODISHA

Khordha
ORISSA
751003
India 
Phone  9937428181  
Fax    
Email  bikashkar@soa.ac.in  
 
Source of Monetary or Material Support
Modification(s)  
Institute of Medical Sciences and Sum Hospital, India, Bhubaneswar, Odisha- 751003 
 
Primary Sponsor
Modification(s)  
Name  Institute of Medical Sciences and Sum Hospital 
Address  Institute of Medical Sciences and Sum Hospital, India, Odisha, Bhubaneswar -751003 
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 
Biswajit Panda  Institute of Medical Sciences and Sum Hospital  Institute of Medical Sciences and Sum Hospital ,Ground Floor , Department of Dermatology ,Kalinga Nagar, BBSR,ODISHA-751003
Khordha
ORISSA 		 08984431027

biswajitdon3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE IMS AND SUM HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L80||Vitiligo,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Adults more than 18 years of age diagnosed with clinical facial vitiligo/ melasma.
2. Adults more than 1 year duration history 
 
ExclusionCriteria 
Details  1. Pregnancy and lactation.
2. Patients with pre-existing psychiatric comorbidities.
3.Patients who are unwilling to participate.
4. Patients having vitiligo in other body areas. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess and compare social acceptance in patients with facial melasma versus facial vitiligo.  At Baseline. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess & compare Body image, Self esteem & quality of life between facial melasma versus facial vitiligo.  At Baseline. 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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)   20/10/2025 
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="0"
Months="6"
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-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [biswajitdon3@gmail.com].

  6. For how long will this data be available start date provided 12-10-2025 and end date provided 19-02-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This is a cross sectional observational study . Primary Aim of the study is to compare social acceptance between facial vitiligo and melasma. Secondary aim is to compare body image, self esteem and quality of life in facial vitiligo versus facial melasma patients. Total 92 patients were enrolled in the study ( 46 in vitiligo, 46 in melasma). F-VASI and MSI was calculated for each patient. Dermoscopy was done. 4 questionaare was given to individual patients and questions were asked . MC.SDS questionnare was used for assessing social acceptance where as Rosenberg self esteem scale was used for assessing self esteem. DLQI was asked. Body image questionnare was asked pertaining to body image.  
Close