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CTRI Number  CTRI/2024/04/065201 [Registered on: 04/04/2024] Trial Registered Prospectively
Last Modified On: 03/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Compare hair cells versus skin cells for vitiligo treatment 
Scientific Title of Study   RANDOMISED CONTROLLED STUDY OF EFFICACY OF NCORSHFS (NON-CULTURED EXTRACTED OUTER ROOT SHEATH HAIR FOLLICLE CELLULAR SUSPENSION) VERSUS NCES (NON-CULTURED EPIDERMAL SUSPENSION) IN STABLE VITILIGO 
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 Revathi S 
Designation  Junior resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 
Address  Department of Dermatology, Dhanvanthri nagar, gorimedu, pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  09566526553  
Fax  4132296000  
Email  revathyjaya3@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rashmi Kumari 
Designation  Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 
Address  Department of Dermatology Jawaharlal Institute of Postgraduate Medical Education and Research Gorimedu, Dhanvantary nagar post ,Pondicherry 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  9655882199  
Fax  4132296000  
Email  rashmi.sreerag@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rashmi Kumari 
Designation  Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 
Address  Department of Dermatology Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Gorimedu Dhanvantary nagar post Pondicherry 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  9655882199  
Fax  4132296000  
Email  rashmi.sreerag@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 
 
Primary Sponsor  
Name  Jawaharlal institute of postgraduate medical education and research 
Address  JIPMER Dhanvantri Nagar Gorimedu Pondicherry -605006 
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 Revathi S  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER),   Opd No -85 Room No :9 Department of Dermatology
Pondicherry
PONDICHERRY 		 09566526553
-
revathyjaya3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
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, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  (Non-cultured extracted outer root sheath hair follicle cellular suspension)  25-30 hair follicles will be taken from occiput area of scaLP which is the donor site based on the recipient area, grafts will be trypsinized and incubated , final Outer root sheath cellular suspension will be centrifuged and final pellet obtained, which is applied over recipient site after manual dermabrasion. Total duration of intervention :3 to 4 hrs 
Comparator Agent  NCES(non cultured epidermal suspension)  skin graft from lateral side of thigh will be taken based on donor:recipient ratio (1:10)and grafts will be trypsinized and epidemal layer will be separated from dermis , melanocyte cellular suspension will be obtained , which is centrifuged and final pellet is obtained. which will be applied over another recipient vitiligo patch. Duration of intervention- 3 to 4 hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Age more than 18 years
No disease activity for the past 6 months.
Not responding to any medical treatmentT 
 
ExclusionCriteria 
Details  Patient with a history of koebnerization.
Lesion exclusively over the bony prominence, over the genital and oral mucosa.
Patient with keloidal tendency.
Patient with a bleeding disorder history.Patient having an active infection at the local site.
Pregnancy, lactation, and serious medical illness.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of 2 surgical procedures i.e. NCORSHFS (Non-cultured extracted
outer root sheath hair follicle cellular suspension) versus NCES (Non-cultured epidermal
suspension) in the treatment of stable vitiligo at 6 months of follow-up 		 Baseline,6 months of follow-up 
 
Secondary Outcome  
Outcome  TimePoints 
To find out the complication rate between two groups
2. To find out the mean duration to achieve 50% repigmentation in both groups at every month
of follow-up. 		 6 months 
 
Target Sample Size   Total Sample Size="14"
Sample Size from India="14" 
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 4 
Date of First Enrollment (India)   15/04/2024 
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  
Vitiligo is an acquired pigmentation disorder manifesting as depigmented lesions
predominantly affecting, skin and mucous membranes due to the loss of melanocytes.1 This
causes significant psychological impact and social stigma among affected individuals.
Researchers are always trying to develop newer modalities of treatment.[2, 3]
Medical treatments like topical steroids, calcineurin inhibitors, and phototherapy are tried as
the first line of treatment but in many cases, optimal results are not achieved.1 Later many
surgical modalities were developed to treat stable vitiligo which included tissue graft (punch,
blister, and split skin grafts) and cellular suspension (melanocyte keratinocyte suspension)
etc.1
Surgical modalities are considered for lesions refractory to medical treatment and non-hairy
sites like lips, and nipple areola complex where repigmentation will be unsatisfactory. NCES
(Non-cultured epidermal suspension). has become a popular surgical modality for stable
vitiligo as it can repigment maximum area compared to all other methods with 1: 10 donorrecipient
ratio, and gives exceptional color matching.[2, 4]
Newer techniques like NCORSHFS (Non-cultured extracted outer root sheath hair follicle
cellular suspension) are emerging, considering hair follicles have a rich source of melanocytes.2
Follicular melanocytes are dendritic and with larger melanosomes compared to those in the
epidermis. The ratio between melanocyte and keratinocyte is 1:6 in the hair follicle whereas it
is 1:36 in the epidermis. This method gives satisfactory repigmentation with excellent color
match.2 Also other advantages are technically less challenging, not requiring mechanical
separation of the epidermis from the underlying dermis, relatively safer, and minimal donor
site complications compared to NCES makes NCORSHFS a useful alternative surgical
modality in the treatment of stable vitiligo.4 There are very few studies comparing the efficacy
of NCORSHFS versus NCES in literature as this technique is relatively new.
Many studies have shown the comparative better efficacy of epidermal cell suspension (NCES)
over NCORSHFS (Non-cultured extracted outer root sheath hair follicle cellular suspension).
Our study will assess the comparative efficacy and side effects of NCORSHFS versus NCES
in the treatment of stable vitiligo.
 
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