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A clinical trial to compare the result of two methods of vitiligo surgery, standard non-cultured epidermal cell suspension (NCES) and no laboratory epidermal cell paste (NLEP), in patients with stable vitiligo

A comparative study evaluating the efficacy of non-cultured epidermal cell suspension (NCES) versus no laboratory epidermal cell paste(NLEP) in stable vitiligo: A randomised controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075147
Enrollment
42
Registered
2024-10-11
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

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: No Laboratory Epidermal cell paste (NLEP): After recruitment, stable vitiligo patches will be randomly assigned to treatment groups 1 or 2 using a random number table. If the patient ha

Sponsors

Dr Anil Budania
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patches of vitiligo with 1. Either lack of progression of old lesions within the past 1 year or repigmentation of depigmented areas 2. Lesions not responding to medical management 3. Age =15 years

Exclusion criteria

Exclusion criteria: 1.Presence of any of the following: immunocompromised, comorbidities like uncontrolled diabetes, hypertension. 2. Chronic diseases affecting wound healing: kidney, liver, chronic congestive failure 3. Bleeding diathesis 4. History of hypertrophic scar or keloid 5. Pregnancy 6. Age below 15 years 7. Denied consent 8. Positive for HIV, HBsAg or HCV

Design outcomes

Primary

MeasureTime frame
To compare NCES and NLEP cellular grafting techniques in stable vitiligo regarding the percentage of repigmentation in lesions.Timepoint: 4 months post intervention—

Secondary

MeasureTime frame
To compare quality of life measured using a validated toolTimepoint: at baseline and 4 months after intervention;To compare the difference in adverse effects profile between NCES and NLEPTimepoint: at baseline and 4 months after intervention;To compare the difference in the viability of melanocytes between the two techniques using trypan blue stainingTimepoint: at the time of intervention;To compare the pattern and colour of repigmentation of vitiligo lesionTimepoint: 4 months after intervention—

Countries

India

Contacts

Public ContactAnil Budania

AIIMS JODHPUR

anilbuddy25@gmail.com921689912765

Outcome results

None listed

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