Comparison of Surgical Methods on Resistant Sites in Stable Vitiligo Patients
- Conditions
- Vitiligo
- Interventions
- Procedure: MINI PUNCH GRAFTINGProcedure: SUCTION BLISTER EPIDERMAL GRAFTINGProcedure: NON CULTURED EPIDERMAL CELL SUSPENSION
- Registration Number
- NCT03717025
- Lead Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Brief Summary
Comparing the Efficacy of Three Different Surgical Methods on Resistant Sites in Stable Vitiligo.
- Detailed Description
The treatment of vitiligo includes both medical and surgical modalities, whose goal is to restore melanocytes to the depigmented skin so that the epidermis restores back to normal morphology and functions. Although medical treatment is the main stay of treatment, it is not effective in all and residual lesions need augmented surgical treatment later for further completion of repigmentation.
Now a day surgical modalities have become treatment of choice for stable vitiligo not responding to medical treatment although there are numerous sites which do not respond that well to surgical procedure as well. The investigators ought to compare the efficacy of 3 well established surgical methods i.e. Mini Punch Grafting vs Suction Blister Epidermal Grafting vs Non Cultured Epidermal cell Suspension on stable vitiligo patches localized to acral areas and bony prominences like elbows, knees and ankles. Out of all the vitiligo patches in a given participant, 3 different patches on acral and bony areas will be chosen and participants will be treated with 3 different methods.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- Subjects with clinical diagnosis of focal, segmental or generalized vitiligo
- Patients with lesions of size > 1.5cm x 1cm present on acral areas and bony prominences.
- Vitiligo lesions has been stable for 1 year.
- Disease not responding to medical treatment, or there are residual patches (after medical therapy) of vitiligo which inturn are located on acral areas and bony prominences.
- Maximum size of vitiligo patches to be selected for surgery will not be >100cm2.
- Age less than 18 years
- Pregnancy and lactation
- Patient with actively spreading vitiligo
- History of Koebnerisation
- History of hypertrophic scars or keloidal tendency
- Bleeding disorders
- Patients with unrealistic expectation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mini Punch Grafting MINI PUNCH GRAFTING - Suction Blister Epidermal Grafting SUCTION BLISTER EPIDERMAL GRAFTING - Non Cultured Epidermal Cell Suspension NON CULTURED EPIDERMAL CELL SUSPENSION -
- Primary Outcome Measures
Name Time Method Repigmentation At Surgery Site Repigmentation will be assessed at 12 weeks. To assess the difference in extent of repigmentation of the surgery site by three different methods at 12 weeks of post treatment follow up in a given patient.
Repigmentation will be assessed as follows:
ā¤25% Minimal repigmentation 26-50% Mild repigmentation 51-75% Moderate repigmentation 76-90% Marked repigmentation \>90% Excellent repigmentation
- Secondary Outcome Measures
Name Time Method Color Matching of Repigmented Area Assessment at 12 weeks. Color matching of the repigmented area with the surrounding normal skin will be done in each case as 'somewhat lighter than', 'same as' or 'somewhat darker than' normal skin.
Patient's Quality of Life Post Surgery Assessment at 12 weeks. Quality of life assessement post procedure will be done using Vitiligo specific questionnaire.
PATTERN OF REPIGMENTATION Assessment at 12 weeks. Pattern of repigmentation attained post-procedure will be noted as 'diffuse', 'perifollicular' or 'migrating from the borders'.
ADVERSE EVENTS Assessment at 4, 8 and 12 weeks. Adverse events both at recipient and donor sites.
Trial Locations
- Locations (1)
Post Graduate Institute of Medical Education and Research
š®š³Chandigarh, India