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A study comparing two skin grafting techniques, with and without immune-modulating medicines, to achieve repigmentation in stable vitiligo at difficult-to-treat sites

A comparative study evaluating the efficacy of Non-Cultured Epidermal Cell Suspension (NCES) versus Suction Blister Epidermal Grafting (SBEG), with and without systemic immunomodulators in stable vitiligo at treatment-resistant sites: A Quasi Randomised Control Trial - nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110039
Enrollment
48
Registered
2026-05-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: L80- Vitiligo

Interventions

Intervention1: With immunomodulator -Tab. Tofacitinib 5mg PO OD for 7 days followed by Tab Tofacitinib 5mg BD from POD14 for 3months: Non-cultured epidermal cell suspension (NCES) and/or suction blist

Sponsors

AIIMS Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Lesional stability assessed clinically & dermoscopically greater than 6 months(greater than 3 months if psychologically distressing). 2. Subjects with vitiligo lesions at treatment resistant sites eyelids, lips, bony prominences & distal extremities. 3. Focal vitiligo of size greater than 5cm. 4. Age 18 to 60 years 5. Provide consent for surgery & follow up.

Exclusion criteria

Exclusion criteria: 1. Unstable lesions either clinically & or dermoscopically. 2. Lesions exclusively on palms & soles, genitalia. 3. Patch size greater than 100 cm2 4. Pregnancy or Lactation 5. Bleeding diathesis 6. Keloidal tendencies 7. Presence of any of the following: immunocompromised, uncontrolled diabetes, chronic kidney disease. 8. Any known hypersensitivity or contraindication to immunomodulators or local anesthesia. 9. Consent denied.

Design outcomes

Primary

MeasureTime frame
To compare the extent of repigmentation between NCES and SBEG at treatment-resistant sites in stable vitiligo.Timepoint: day7,day14,day28,2months,3months,4months,5months

Secondary

MeasureTime frame
To assess the effect of postoperative systemic therapy (Tofacitinib 5mg BD) on repigmentation following vitiligo surgeryTimepoint: day7,day14,day28,2months,3months,4months,5months;To compare the pattern of repigmentation.Timepoint: day7,day14,day28,2months,3months,4months,5months;To compare the colour matchTimepoint: day7,day14,day28,2months,3months,4months,5months;To assess complications of different surgical modalities & medical therapies.Timepoint: day7,day14,day28,2months,3months,4months,5months;To assess the quality of life before and after surgery.Timepoint: day7,day14,day28,2months,3months,4months,5months

Countries

India

Contacts

Public ContactDr Saurabh Singh

All India Institute of Medical Sciences, Jodhpur

saurabhdoc@yahoo.co.in9968024250

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026