| 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.
|
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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 |
|
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Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry |
|
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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 |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80||Vitiligo, |
|
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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. |
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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
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Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
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Method of Concealment
|
On-site computer system |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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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 |
|
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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 |
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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" |
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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 |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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. |