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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- To compare NCES and NLEP cellular grafting techniques in stable vitiligo regarding the percentage of repigmentation in lesions.
Study Overview
Brief Summary
The study is a prospective, simple randomized clinical trial, recruiting patients from the department of Dermatology, Venereology and Leprology OPD, AIIMS, Jodhpur. The patches will be randomised with group 1 and group 2. If one patient has two patches, the upper and left patch will be recruited to the randomised group and the other patch will automatically allocated the other group. Patches in group 1 will undergo standard NCES procedure and those in group 2 will undergo NLEP. Patients will be followed up in OPD on day 8 (dressing removal), and 1st, 2nd, 3rd and 4th month after the transplantation. Percentage of repigmentation assessment as per graphical assessment will be done.
Research question is to compare the efficacy and safety of standard noncultured epidermal cell suspension (NCES) method with newer no laboratory epidermal paste (NLEP) modification in stable vitiligo patches.
Primary objective is to compare NCES and NLEP cellular grafting techniques in stable vitiligo regarding the percentage of repigmentation.
Secondary objective is to compare pattern and colour of re-pigmentation of vitiligo lesion, adverse effects profile in NCES and NLEP, the difference in the viability of melanocytes between the two techniques and to compare quality of life measured using VIS22 score.
Incusion criteria is stable vitiligo patches with either lack of progression of old lesions within the past 1 year or repigmentation of depigmented areas, lesions not responding to medical management, Age ≥15 years
Exclusion criteria is presence of any of the following: immunocompromised, comorbidities like uncontrolled diabetes, hypertension, Chronic diseases affecting wound healing, kidney, liver, chronic congestive failure, Bleeding diathesis, History of hypertrophic scar or keloid, Pregnancy, Age below 15 years, Denied consent or Viral HIV, HBsAg or HCV status
We are expecting NLEP to be non-inferior to NCES.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 15.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patches of vitiligo with
- •Either lack of progression of old lesions within the past 1 year or repigmentation of depigmented areas
- •Lesions not responding to medical management
- •Age ≥15 years.
Exclusion Criteria
- •1.Presence of any of the following: immunocompromised, comorbidities like uncontrolled diabetes, hypertension.
- •Chronic diseases affecting wound healing: kidney, liver, chronic congestive failure
- •Bleeding diathesis
- •History of hypertrophic scar or keloid
- •Pregnancy
- •Age below 15 years
- •Denied consent
- •Positive for HIV, HBsAg or HCV.
Outcomes
Primary Outcomes
To compare NCES and NLEP cellular grafting techniques in stable vitiligo regarding the percentage of repigmentation in lesions.
Time Frame: 4 months post intervention
Secondary Outcomes
- To compare the pattern and colour of repigmentation of vitiligo lesion(4 months after intervention)
- To compare the difference in adverse effects profile between NCES and NLEP(at baseline and 4 months after intervention)
- To compare the difference in the viability of melanocytes between the two techniques using trypan blue staining(at the time of intervention)
- To compare quality of life measured using a validated tool(at baseline and 4 months after intervention)
Investigators
Anil Budania
AIIMS JODHPUR