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.

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 - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/095922

Enrollment

Registered

2025-10-13

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L80- Vitiligo

Interventions

Intervention1: 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 graft

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.Timepoint: Baseline,6 months	—

Measure

Time frame

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.Timepoint: Baseline,6 months

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Secondary

Measure	Time frame
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 monthsTimepoint: Baseline,6 months,1 year	—

Measure

Time frame

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 monthsTimepoint: Baseline,6 months,1 year

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Countries

India

Contacts

Public ContactDr Laxmisha Chandrashekar

Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry

laxmishac@gmail.com9894119058

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026