- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03717025
Comparison of Surgical Methods on Resistant Sites in Stable Vitiligo Patients
A Comparative Study Between Autologous Mini Punch Grafting, Suction Blister Grafting and Non-Cutured Epidermal Cell Suspension on Resistant Sites in Stable Vitiligo
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Chandigarh, India, 160012
- Recruiting
- Post Graduate Institute of Medical Education and Research
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Contact:
- MUTHU SENDHIL KUMARAN, ASSOCIATE PROFESSOR
- Phone Number: 91 9876930521
- Email: drsen_2000@yahoo.com
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Contact:
- AMIT KUMAR, JUNIOR RESIDENT
- Phone Number: 91 7347638076
- Email: amitdalla615@gmaiil.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Mini Punch Grafting
|
|
Active Comparator: Suction Blister Epidermal Grafting
|
|
Active Comparator: Non Cultured Epidermal Cell Suspension
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
Repigmentation will be assessed at 12 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Assessment at 12 weeks.
|
Patient's Quality of Life Post Surgery
Time Frame: Assessment at 12 weeks.
|
Patient satisfaction will be assessed using Patient Global Assessment score.
|
Assessment at 12 weeks.
|
Patient's Quality of Life Post Surgery
Time Frame: Assessment at 12 weeks.
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Quality of life assessement post procedure will be done using Vitiligo specific questionnaire.
|
Assessment at 12 weeks.
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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'.
|
Assessment at 12 weeks.
|
ADVERSE EVENTS
Time Frame: Assessment at 4, 8 and 12 weeks.
|
Adverse events both at recipient and donor sites.
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Assessment at 4, 8 and 12 weeks.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- INT/IEC/2017/1251
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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