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CTRI Number  CTRI/2018/07/014871 [Registered on: 16/07/2018] Trial Registered Prospectively
Last Modified On: 29/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Surgical Management of stable vitiligo. 
Scientific Title of Study   A Comparative study between Autologous Mini punch grafting, Suction blister grafting and Non Cultured Epidermal cell suspension on resistant sites in stable vitiligo. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  AMIT KUMAR 
Designation  JUNIOR RESIDENT 
Affiliation  DEPARTMENT OF DERMATOLOGY, POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH. 
Address  ROOM NO 8, DEPARTMENT OF DERMATOLOGY, BLOCK F,NEHRU HOSPITAL POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH

Chandigarh
CHANDIGARH
160012
India 
Phone  7347638076  
Fax    
Email  amitdalla615@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  M SENDHIL KUMARAN  
Designation  ASSOCIATE PROFESSOR 
Affiliation  DEPARTMENT OF DERMATOLOGY, POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH. 
Address  ROOM NO 8, DEPARTMENT OF DERMATOLOGY, BLOCK F,NEHRU HOSPITAL POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  drsen_2000@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  M SENDHIL KUMARAN  
Designation  ASSOCIATE PROFESSOR 
Affiliation  DEPARTMENT OF DERMATOLOGY, POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH. 
Address  ROOM NO 8, DEPARTMENT OF DERMATOLOGY, BLOCK F,NEHRU HOSPITAL POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  drsen_2000@yahoo.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF DERMATOLOGY, PGIMER, CHANDIGARH - 160012. 
 
Primary Sponsor  
Name  DEPARTMENT OF DERMATOLOGY 
Address  POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH - 160012 
Type of Sponsor  Government 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 
AMIT KUMAR  POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH (PGIMER)  DEPARTMENT OF DERMATOLOGY, NEW OPD,5TH FLOOR, ROOM NO 5015 POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH - 160012
Chandigarh
CHANDIGARH 
7347638076

amitdalla615@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  HAVING STABLE VITILIGO ON RESISTANT SITES LIKE ACRAL AREAS AND BONY PROMINENCES., (1) ICD-10 Condition: L80||Vitiligo,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AUTOLOGOUS MINI PUNCH GRAFTING, SUCTION BLISTER GRAFTING AND NON-CULTURED EPIDERMAL CELL SUSPENSION.  Compare extent of repigmentation after 12 weeks of procedure.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Subjects with clinical diagnosis of focal, segmental or generalized vitiligo.
2. Patients with lesions of size > 1.5cm x 1cm present on acral areas and bony prominences.
3. Vitiligo lesions has been stable for 1 year.
4. Disease not responding to medical treatment or there are residual patches (after medical therapy) of vitiligo which in turn are located on acral areas and bony prominences.
5. Maximum size of vitiligo patches to be selected for surgery will not be >100cm2.
 
 
ExclusionCriteria 
Details  1) Age less than 18 years
2) Pregnancy and lactation
3) Patient with actively spreading vitiligo
4) History of Koebnerisation
5) History of hypertrophic scars or keloidal
tendency
6) Bleeding disorders
7) Patients with unrealistic expectation
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the difference in extent of repigmentation by three different methods at 12 weeks of post treatment follow up in a given patient.
 
Follow up will be done on Day 8, then at 4, 8 and 12 weeks.
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Pattern of repigmentation
attained post-procedure.
2. Color matching of
repigmented area.
3. Patient satisfaction
(patient global assessment)
and quality of life
assessement post procedure.
4. Adverse events if any.
 
Follow up will be done on Day 8,then at 4,8 and 12 weeks. 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/07/2018 
Date of Study Completion (India) 31/12/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="10" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
NONE YET 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  
The treatment of vitiligo includes both medical and surgical modalities, whose goal is to restore melanocytes to the depigmented skin so that the epidermis restores back to normal morphology and functions. Although medical treatment is the mainstay of treatment, it is not effective all and residual lesions need augmented surgical treatment for further completion of repigmentation. Also there are certain areas that are difficult to repigment such as vitiligo patches on joints and bony prominences, lips, genitalia, dorsum of hands and feet especially fingers and toes. Proper selection of cases for surgical therapy is of paramount importance and stability of vitiligo is taken as the most important parameter before opting for any surgical intervention. The recommended period of stabilty in different studies varied widely from 4 months to 3 years, but none of these criteria were based on evidence obtained from systematic research.
Not many studies have been conducted analyzing the efficacy of various surgical modalities in vitiligo patches located over treatment refractory areas like acral and bony sites, genital areas,lips, palms and soles. Through this study we shall compare the effectiveness of 3 well established surgical methods - Autologous Mini Punch grafting, Suction blister epidermal grafting and Non cultured epidermal cell suspension on treatment resistant vitiligo lesions present over bony prominences and acral areas( mainly distal areas) with regards to extent of repigmentation, color matching of repigmented area, patient satisfaction and adverse effects if any.
 
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