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CTRI Number  CTRI/2021/07/034757 [Registered on: 12/07/2021] Trial Registered Prospectively
Last Modified On: 27/12/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Correlation of dermatoscopic features of vitiligo with disease activity 
Scientific Title of Study   A study to sequentially determine the dermatoscopic features of vitiligo and its correlation with disease activity and treatment response 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priyansh Gupta 
Designation  Junior Resident 
Affiliation  PGIMER Chandigarh 
Address  694 Sector 11B near architect girls hostel Chandigarh 160011
694 Sector 11B near architect girls hostel Chandigarh 160011
Chandigarh
CHANDIGARH
160011
India 
Phone  7409401008  
Fax    
Email  priyansh.gupta2412@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vinay K 
Designation  Assistant Professor 
Affiliation  PGIMER Chandigarh 
Address  Department of Dermatology PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  8872993222  
Fax    
Email  vinay.keshavmurthy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vinay K 
Designation  Assistant Professor 
Affiliation  PGIMER Chandigarh 
Address  Department of Dermatology PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  8872993222  
Fax    
Email  vinay.keshavmurthy@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Medical Education and Research Chandigarh 160012 
 
Primary Sponsor  
Name  Department of Dermatology  
Address  PGIMER Chandigarh 
Type of Sponsor  Research institution and hospital 
 
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 
Priyansh Gupta  PGIMER   Department of Dermatology PGIMER Chandigarh
Chandigarh
CHANDIGARH 
7409401008

priyansh.gupta2412@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PGIMER  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  Not Applicable  Not Applicable 
Intervention  Not Applicable   Not applicable 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. A clinical diagnosis of vitiligo (segmental or non-segmental type)
2. Active disease defined as VIDA score of 4+
3. Two independent areas/lesions of of size 2 x 2 cm to 6 x 6 cm showing clinical signs of progressive vitiligo
4. Patients who are yet to be initiated on medical management. A wash off period of 4 weeks for topical and 12 weeks for systemic treatment will be ensured. 
 
ExclusionCriteria 
Details  1. Stable disease
2. Patients with only mucosal vitiligo
3. Patients receiving phototherapy or surgical management
4. Patients who refuse to give consent for participation in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To sequentially determine the dermatoscopic features of vitiligo  Baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. To correlate the dermatoscopic features with disease activity assessed by means of VIDA and VASI.
2. To correlate the dermatoscopic features of repigmentation with treatment modality used. 
4 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/07/2021 
Date of Study Completion (India) Date Missing 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Vitiligo is one of the common acquired pigmentary disorders, which is characterized by depigmentation as a result of the loss of melanin producing cells also known as melanocytes. The prevalence rate of vitiligo in the world approximates around 1%, while in India it goes up to 8.8%, making it a significant proportion of patients seen in dermatology services. The dark complexion of ethnic skin combined with social stigma and lack of knowledge about the disease in the general population causes a lot of psychological distress to affected patients.
Vitiligo is characterized by milky or ivory white sharply demarcated macules, often symmetrical on both sides of the body. The size of the lesions may vary from a few millimetres to several centimetres. The most common sites affected are the ones which are prone to repeated trauma or chronic pressure or friction like hips, dorsum of hands and feet, ankles, elbows and knees. The natural course of the disease is highly unpredictable as well, with periods of abrupt onset, active disease, then stability or repigmentation and rapid progression after a period of dormancy.
There are many theories and hypothesis suggesting the pathophysiology of vitiligo: genetic, biochemical, neural, autoimmune, defective free radical defence, etc. In spite of this, vitiligo still remains an idiopathic disorder, with more than one factor at play in a single individual.
Conventional medical therapies have used both topical and oral treatment. First line therapies are usually topical steroids or topical calcineurin inhibitors like tacrolimus.3 Oral mini pulse therapy using dexamethasone is used for rapidly progressive or active disease and has shown to halt the disease activity and caused repigmentation in some patients.3 Other therapies like antioxidants, systemic phototherapy i.e. psoralen and ultraviolet A (PUVA), ultraviolet B (UVB) therapy, laser therapy are also being used. Surgery as a therapeutic option is kept for patients who have stable disease and are not responding to medical therapies. This mostly includes autologous grafting techniques, both tissue and cellular (both cultured and non-cultured).
 
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