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CTRI Number  CTRI/2024/11/077162 [Registered on: 21/11/2024] Trial Registered Prospectively
Last Modified On: 17/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Comparing two different skin treatments to restore Color in Vitiligo patches: A study using patients own skin cells and a new printing technology 
Scientific Title of Study   Comparison of Non-Cultured Epidermal Cell Suspension (NCES) and 3D Bioprinting of Autologous Melanocytes for the Treatment of Vitiligo: A Pilot 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 Shrinivas Patil 
Designation  Resident Dermatology, Venereology and Leprosy 
Affiliation  Command Hospital Air Force Bangalore, Indian Air Force 
Address  Command hospital Air Force, Cambridge road, Bangalore-560007 Command hospital Air Force, Cambridge road, Bangalore-560007

Bangalore
KARNATAKA
560007
India 
Phone  8867659749  
Fax    
Email  shrinivas93doctor@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Debdeep Mitra 
Designation  Classified Specialist Dermatology, Venereology and Leprosy 
Affiliation  Command Hospital Air Force Bangalore, Indian Air Force 
Address  Department of Dermatology, Venereology and Leprosy, Command Hospital Air Force, Bangalore-560007 Department of Dermatology, Venereology and Leprosy, Command Hospital Air Force, Bangalore-560007

Bangalore
KARNATAKA
560007
India 
Phone  08811851830  
Fax    
Email  debdeep5000@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Debdeep Mitra 
Designation  Classified Specialist Dermatology, Venereology and Leprosy 
Affiliation  Command Hospital Air Force Bangalore, Indian Air Force 
Address  Department of Dermatology, Venereology and Leprosy, Command Hospital Air Force, Bangalore-560007 Department of Dermatology, Venereology and Leprosy, Command Hospital Air Force, Bangalore-560007

Bangalore
KARNATAKA
560007
India 
Phone  08811851830  
Fax    
Email  debdeep5000@gmail.com  
 
Source of Monetary or Material Support  
Department of Dermatology, Venereology and Leprosy, Command Hospital Air Force, Bangalore- 560007 
 
Primary Sponsor  
Name  Command Hospital Air Force Bangalore 
Address  COMMAND HOSPITAL AIR FORCE, CAMBRIDGE ROAD, BANGALORE-560007 
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 
Dr Shrinivas Patil  Command Hospital Air Force Bangalore  Room no 6, Department of Dermatology,Venere ology and Leprosy, Command hospital Air Force, Cambridge road, Bangalore-560007
Bangalore
KARNATAKA 
8867659749

shrinivas93doctor@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical committee reviewers, Command Hospital Air Force Bangalore  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  3D bioprinting  For 3D bioprinting, autologous skin samples will be taken from the patients with vitiligo using dermatome after local anestheseia with injection lignocaine (donor area), melanocytes will be isolated, and these cells will be mixed with hydroxymethylcellulose gel to create a bioink. A BIO X 3D bioprinter will be utilized used to print the bioink into skin substitutes, which will then be applied onto dermabraded vitiligo patches. Duration of treatment is around 3-4 hours total, and single sitting is done for each vitiligo patch. 
Comparator Agent  Non-Cultured Epidermal Cell Suspension (NCES)   For NCES, a thin shave biopsy of healthy skin will be taken after local anesthesia using injection lignocaine, and the epidermis and dermis will be separated via enzyme digestion (Trypsin). The resulting suspension, containing melanocytes, will be applied onto dermabraded vitiligo patches. Duration of treatment is around 3-4 hours total, and single sitting is done for each vitiligo patch. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  (a) Stable vitiligo for at least 12 months.
(b) Age between 18-45 years.
(c) Vitiligo patches located on accessible body areas (face, limbs, torso).
(d) No prior cellular transplantation on the selected patches.
 
 
ExclusionCriteria 
Details  (a) Active vitiligo.
(b) Comorbid conditions such as diabetes or autoimmune diseases.
(c) Pregnancy or lactation.
(d) History of keloid or hypertrophic scar formation.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Rate of repigmentation of vitiligo patches   over 3 to 4 months 
 
Secondary Outcome  
Outcome  TimePoints 
(a) Patient Satisfaction
(b) Safety & Tolerability
(c) Feasibility of 3D Bioprinting Process 
6 to 7 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   Phase 3 
Date of First Enrollment (India)   10/12/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  
This prospective pilot study is designed to evaluate and compare the efficacy of Non-Cultured Epidermal Cell Suspension (NCES) and 3D bioprinting of autologous melanocytes in the treatment of vitiligo, with repigmentation rate as the primary endpoint. A total of 32-34 stable vitiligo patches will be included, with each treatment arm receiving 16-17 patches. For NCES, a suspension of melanocytes from a thin skin biopsy will be applied to dermabraded patches. In the 3D bioprinting arm, melanocytes isolated from autologous skin will be mixed with hydroxymethyl cellulose (HMC) to create a bioink, which will then be printed into skin substitutes and applied to the prepared patches.

Patients will be followed monthly for six months, assessing repigmentation rates through clinical photographs, patient satisfaction on a Visual Analog Scale, and monitoring for any adverse events. It is hypothesized that 3D bioprinting will lead to higher repigmentation rates, improved patient satisfaction, and maintain a strong safety profile. The outcomes of this study are expected to provide insights into the potential of 3D bioprinting as a superior therapeutic alternative in vitiligo management, supporting its use in further clinical studies with larger sample sizes.
 
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