Comparison of Surgical Methods on Resistant Sites in Stable Vitiligo Patients
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|ClinicalTrials.gov Identifier: NCT03717025|
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Vitiligo||Procedure: SUCTION BLISTER EPIDERMAL GRAFTING Procedure: MINI PUNCH GRAFTING Procedure: NON CULTURED EPIDERMAL CELL SUSPENSION||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Comparative Study Between Autologous Mini Punch Grafting, Suction Blister Grafting and Non-Cutured Epidermal Cell Suspension on Resistant Sites in Stable Vitiligo|
|Actual Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||November 2018|
|Active Comparator: Mini Punch Grafting||
Procedure: MINI PUNCH GRAFTING
|Active Comparator: Suction Blister Epidermal Grafting||
Procedure: SUCTION BLISTER EPIDERMAL GRAFTING
|Active Comparator: Non Cultured Epidermal Cell Suspension||
Procedure: NON CULTURED EPIDERMAL CELL SUSPENSION
- Repigmentation At Surgery Site [ Time Frame: 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:
≤25% Minimal repigmentation 26-50% Mild repigmentation 51-75% Moderate repigmentation 76-90% Marked repigmentation >90% Excellent repigmentation
- Color Matching of Repigmented Area [ Time Frame: 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 [ Time Frame: Assessment at 12 weeks. ]Patient satisfaction will be assessed using Patient Global Assessment score.
- Patient's Quality of Life Post Surgery [ Time Frame: Assessment at 12 weeks. ]Quality of life assessement post procedure will be done using Vitiligo specific questionnaire.
- PATTERN OF REPIGMENTATION [ Time Frame: Assessment at 12 weeks. ]Pattern of repigmentation attained post-procedure will be noted as 'diffuse', 'perifollicular' or 'migrating from the borders'.
- ADVERSE EVENTS [ Time Frame: Assessment at 4, 8 and 12 weeks. ]Adverse events both at recipient and donor sites.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717025
|Post Graduate Institute of Medical Education and Research||Recruiting|
|Chandigarh, India, 160012|
|Contact: MUTHU SENDHIL KUMARAN, ASSOCIATE PROFESSOR 9876930521 ext 91 firstname.lastname@example.org|
|Contact: AMIT KUMAR, JUNIOR RESIDENT 7347638076 ext 91 email@example.com|