FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/04/041751 [Registered on: 08/04/2022] Trial Registered Prospectively
Last Modified On: 11/11/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   OPEN LABELLED, SINGLE ARM, INTERVENTIONAL STUDY OF MICRO PUCH GRAFTING FOR VITILIGO. 
Scientific Title of Study   MICRO PUCH GRAFTING (MICRO PG) BY USING MOTORIZED POWER PUNCHES AS A TISSUE EXTRACTOR 0.8 MM IN STABLE AND LIP VITILIGO: A NOVEL APPROACH IN STABLE VITILIGO 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Protocon No:CACS-DS-001, Vesrion.01, Date:17 Jan 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Madura C 
Designation  Lead Consultant Dermatosurgeon Hair Transplantation Surgeon and Consultant Dermatologist 
Affiliation  CUTIS Academy of Cutaneous Sciences 
Address  5/1,4th Main, MRCR Layout Vijayanagar, Bangalore
Department of Dermatosurgery, Room No:10 5/1,4th Main, MRCR Layout Vijayanagar, Bangalore
Bangalore Rural
KARNATAKA
560040
India 
Phone    
Fax    
Email  maduradr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Madura C 
Designation  Lead Consultant Dermatosurgeon Hair Transplantation Surgeon and Consultant Dermatologist 
Affiliation  CUTIS Academy of Cutaneous Sciences 
Address  5/1,4th Main, MRCR Layout Vijayanagar, Bangalore
Department of Dermatosurgery, Room No:10 5/1,4th Main, MRCR Layout Vijayanagar, Bangalore
Bangalore Rural
KARNATAKA
560040
India 
Phone    
Fax    
Email  maduradr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Madura C 
Designation  Lead Consultant Dermatosurgeon Hair Transplantation Surgeon and Consultant Dermatologist 
Affiliation  CUTIS Academy of Cutaneous Sciences 
Address  5/1,4th Main, MRCR Layout Vijayanagar, Bangalore
Department of Dermatosurgery, Room No:10 5/1,4th Main, MRCR Layout Vijayanagar, Bangalore
Bangalore Rural
KARNATAKA
560040
India 
Phone    
Fax    
Email  maduradr@gmail.com  
 
Source of Monetary or Material Support  
CUTIS Academy of Cutaneous Sciens 5/1,4th Main, MRCR layout, Vijayanagar, bangalore 560040 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NIL] 
 
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 Ravikumar S M  CUTIS Academy of Cutaneous Sciences  Department of dermatosurgery, Room No:10 5/1,4th Main, MRCR Layout Vijayanagar, Bangalore
Bangalore Rural
KARNATAKA 
8660619504

ravism64@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CUTIS Institutional Ethics Committee  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 
Intervention  Micro punch grafting  The patients were assessed every 15 days for 3 months and once a month for the next 3 months. 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age > 15 years
2. The vitiligo stability of at least 12 months
3. Patient not responding to medical management 
 
ExclusionCriteria 
Details  1. Unstable vitiligo
2. Tendency for hypertrophic and keloid scars
3. History of bleeding diathesis
4. Pregnancy and lactation
5. Active infection in Donor or recipient site 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To know the efficacy of repigmentation in stable lip Vitiligo by motorized motorized micro punch grafting technique  After 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
To know the Side effect profile of the motorized MPG technique  After 3 months 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/04/2022 
Date of Study Completion (India) 06/09/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 06/09/2022 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Vitiligo is a common disorder of pigmentation.1 Pathogenetically, vitiligo represents a complex reaction pattern involving multiple etiologic factors, some of them necessarily working in concert. On-going research is focussing on a better understanding of pathogenesis and thus searching for better treatment modalities. Treatment is classified into medical, light-based, surgical, camouflage, and depigmentation therapy2.

Surgical treatment is generally considered when medical/light-based treatment has failed and includes tissue transfer (e.g., punch grafting, partial split-thickness grafting, and suction blister grafting) and cellular transfer, which is further divided into cultured and non-cultured techniques.3-5  The basic principle of surgical treatment is to transfer the melanocytes from normal skin to-vitiliginous skin. Non-cultured epidermal cell suspension (NCES) is considered the standard and most effective surgical treatment for stable vitiligo and, it along with suction blister grafting (SBG), has a better outcome than other surgical methods.6

Autologous mini punch grafting is the easiest, effective, and less expensive method of vitiligo surgery. It is indicated in almost all sites especially in acral vitiligo involving palms, fingers, nipples, and lips.7

The technique of Mini punch grafting (MPG)  has undergone many modifications over the years to reduce the requirement for equipment and to save time. The time consumed in MPG using punches of less than 1.5 mm is more when compared with punch grafting with 2-3 mm punches, moreover the number of grafts required is also more with a decrease in punch sizes. With the advent of motorized power punches the procedure can be done with more ease in lesser time to harvest more mini grafts (<1.5 mm) in a single session.7

A newer technique of Motorized 0.8-mm micro punch grafting for refractory vitiligo from a retrospective study of 230 cases concluded that refractory vitiligo with short procedure times had an excellent outcome. This technique could be a rapid and convenient surgical option with acceptable adverse events and is promising for treating refractory vitiligo on an outpatient basis, particularly in patients who are unlikely to tolerate prolonged surgery.8

We also want to know the efficacy of the same by doing it in the exclusive lip vitiligo and to look at the adverse effects of the 0.8mm micro punch grafting. 

 
Close