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CTRI Number  CTRI/2025/10/095922 [Registered on: 13/10/2025] Trial Registered Prospectively
Last Modified On: 11/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Study comparing the Effectiveness and Safety of Combining Oral Cyclosporine (a Drug which calms the immune system)with a Skin Cell Transplant Procedure (NCES) for Stable Vitiligo.  
Scientific Title of Study   Efficacy and safety of combined oral cyclosporine and autologous noncultured melanocyte keratinocyte transplantation procedure (NCES) versus only NCES for stable vitiligo: A double-blinded placebo-controlled pilot adaptive randomization trial using minimization 
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 A Swaroopa 
Designation  Junior resident 
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 PONDICHERRY

Pondicherry
PONDICHERRY
605006
India 
Phone  8919881516  
Fax  4132296000   
Email  swaroopaand@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Laxmisha Chandrashekar 
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 PONDICHERRY 605006 India

Pondicherry
PONDICHERRY
605006
India 
Phone  9894119058  
Fax  4132296000   
Email  laxmishac@gmail.com   
 
Details of Contact Person
Public Query
 
Name  Dr Laxmisha Chandrashekar 
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 PONDICHERRY 605006 India

Pondicherry
PONDICHERRY
605006
India 
Phone  9894119058  
Fax  4132296000   
Email  laxmishac@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 (JIPMER), Pondicherry 
Address  JIPMER, Dhanvantri Nagar, Gorimedu, Pondicherry -605006  
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 
Dr A Swaroopa  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)   Opd No -85 Room No :9 Department of Dermatology PUDUCHERRY ,605006 PONDICHERRY Pondicherry
Pondicherry
PONDICHERRY 
8919881516
4132296000
swaroopaand@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES  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  NCES alone with placebo group  Participants will undergo the autologous non-cultured melanocyte–keratinocyte suspension (NCES) procedure for stable vitiligo, along with placebo. NCES procedure: Same as in the intervention group. Placebo: Participants will receive identical-looking placebo (without active medicine) for the same duration as the cyclosporine group. Monitoring and follow-up will be conducted in the same manner as the intervention group. 
Intervention  NCES with cyclosporine 3mg/kg/day for 3 weeks followed by 1.5 mg/kg/day for 6 weeks  skin graft from lateral side of thigh will be taken based on donor :recipient ratio (1:10) and grafts will be trypsinized and epidermal 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 vitiligo patch Duration of intervention is 3-4 hours post operative will start on Oral cyclosporine will be given at a dose of 3 mg/kg/day for 3 weeks, followed by 1.5 mg/kg/day for 6 weeks. Participants will be monitored regularly for blood pressure, blood counts, electrolytes, kidney, and liver function during cyclosporine therapy. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.age more than 18 years
2.patients who are willing to come for 1 year
3.clinically stable vitiligo with vitiligo disease activity score (VIDA) of less than 0
4.vitiligo signs of activity score (VSAS) less than 2 
 
ExclusionCriteria 
Details  1.Patient with contraindications for cyclosporine
2.Uncontrolled hypertension
3.Hypersensitivity to cyclosporine
4.Deranged baseline renal parameters
5.Concomitant use of other nephrotoxic drugs
6.Deranged baseline liver function tests
7.Tuberculosis
8.Immunosuppressed individuals
9.Refractory hyperkalemia, hyperuricemia, hypomagnesemia
10.Pregnancy, lactation and serious medical illness
11.Patient with past or current history of malignancy
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To analyse the efficacy and safety of combined NCES with cyclosporine in comparison to NCES alone as measured baseline and at end of 6 months
1.Morphometry - Extent (surface area) of repigmentation in percentage measured by analysis of images taken through DSLR camera using ImageJ software
2.To compare the quality of repigmentation between the NCES + cyclosporine group and the NCES alone group using a semiquantitative colour match scale, assessed by two independent dermatologists based on standardized clinical photographs.
3.Safety- To assess the incidence and severity of adverse effects in each group at each visit.  
Baseline,6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1)To establish a correlation between baseline lesional CD8+ infiltrate and postoperative outcome in terms of percentage of repigmentation
2)proportion of patients with successful repigmentation
3)To compare the quality of repigmentation between the NCES+CYCLOSPORINE group and NCES with placebo group ,assesed by color difference between repigmented skin and adjacent normal skin
4)To assess the change in DLQI scores from baseline to 6 months and 12 months 
Baseline,6 months,1 year 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2 
Date of First Enrollment (India)   23/10/2025 
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 depigmentation disorder characterized by depigmented lesions resulting from autoimmune destruction of melanocytes. It has a major impact on the quality of life of patients due to low self-esteem esteem and social isolation.

Medical treatments like topical steroids, calcineurin inhibitors, and phototherapy are tried during the active stage of the disease, but in most cases, optimal results are not achieved. Lesions in acral and non hairy regions are often resistant to treatment. Surgical treatment is helpful in such resistant areas and in residual lesions.

Melanocytes can be introduced by cellular or tissue grafts. Surgical treatment  including tissue graft (punch, blister and split skin grafts) and cellular suspension (of cultured or non cultured cells melanocyte keratinocyte suspension) are used to treat stable vitiligo which are refractory to medical treatment. Melanocyte keratinocyte suspension has become popular surgical modality of vitiligo treatment as it can repigment maximum area compared to tissue grafts. However, loss of pigmentation and relapse occurs in few patients.

While vitiligo surgery provides good results in majority of patients, some lesions fail to repigment or lose achieved pigmentation. It usually manifests as a depigmented halo around the treated area(perilesional halo/achromic fissure). This is supposed to be due to cytotoxic CD8+ T cells in the perilesional skin. Cyclosporine is an immunomodulator that acts on Tcells .In this study we are going to compare the outcome after NCES in terms of extent and quality of repigmentation in two groups with and without cyclosporine.

 
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