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Comparing the Efficacy of Three Different Surgical Methods on Resistant Sites in Stable Vitiligo.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mini Punch Grafting | Active Comparator |
| |
| Suction Blister Epidermal Grafting | Active Comparator |
| |
| Non Cultured Epidermal Cell Suspension | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUCTION BLISTER EPIDERMAL GRAFTING | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Repigmentation At Surgery Site | 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: ≤25% Minimal repigmentation 26-50% Mild repigmentation 51-75% Moderate repigmentation 76-90% Marked repigmentation >90% Excellent repigmentation | Repigmentation will be assessed at 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Color Matching of Repigmented Area | 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. | Assessment at 12 weeks. |
| Patient's Quality of Life Post Surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Post Graduate Institute of Medical Education and Research | Recruiting | Chandigarh | 160012 | India |
Overall results of the study will be available to other researchers.
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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|
| MINI PUNCH GRAFTING | Procedure |
|
|
| NON CULTURED EPIDERMAL CELL SUSPENSION | Procedure |
|
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Patient satisfaction will be assessed using Patient Global Assessment score. |
| Assessment at 12 weeks. |
| Patient's Quality of Life Post Surgery | Quality of life assessement post procedure will be done using Vitiligo specific questionnaire. | Assessment at 12 weeks. |
| PATTERN OF REPIGMENTATION | Pattern of repigmentation attained post-procedure will be noted as 'diffuse', 'perifollicular' or 'migrating from the borders'. | Assessment at 12 weeks. |
| ADVERSE EVENTS | Adverse events both at recipient and donor sites. | Assessment at 4, 8 and 12 weeks. |