Transplantation of Basal Cell Layer Suspension Using Derma-rolling System in Vitiligo

Study Overview
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Brief Summary
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Actually the methods for melanocyte delivery are invasive and often sophisticated. The dermarolling system with needles causing tiny microinjuries in the epidermis could offer a minimally invasive and painless method of melanocyte transplantation. The purpose of the study is to develop a new and simple method for transepidermally delivering keratinocytes and melanocytes into vitiligo skin.

Detailed Description
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Condition: stable lesion of non segmental and segmental vitiligo of adults. Background: The best method to transepidermally deliver isolated cells (melanocytes) is not yet defined. Microneedle treatment of the  ex vivo  human skin caused many thin vertical epidermodermal fissures and a variable depth of injury into the dermis regarding the length of the needles. This kind of treatment could be able to create small epidermal defects which allows to deliver melanocytes to an epidermal site. An approach to replenish melanocytes by injection of dissociated epidermal cell suspension with a syringe was recently successfully used. So, we hypothesize that the use of dermaroller with 0.2mm needle length which causes tiny microinjuries strictly in the epidermis could offer a simple, minimally invasive and painless method of melanocyte transplantation. Main objective: To demonstrate the efficacy and the interest of dermaroller use with 0.2mm needle length in the transplantation of basal cell layer suspension in the epidermis of depigmented vitiligo skin. Secondary objectives To assess as control the effect of the use of dermaroller alone on the vitiligo lesion. If transplantation is successful, to assess the duration needed to obtain a good coalescence and a complete repigmentation of the vitiligo lesion.

Official Title
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Transplantation With Dermarolling System of Basal Cell Layer Suspension Obtained by Soft Trypsinisation in Vitiligo Lesion

Conditions
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Vitiligo

Intervention / Treatment
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* Device: Dermabrasion with dermaroller


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non segmental and segmental vitiligo lesions stable for a minimum of 1 year prior surgery Men and women aged over 18 years of age The lesion area must be 2cm2< lesion< 15cm2 Absence of infected lesion Exclusion Criteria: Actively spreading vitiligo (unstable disease) Patient with history of melanoma Infected lesions Positive Koebner Phenomenon History of hypertrophic scars or keloid formation Treatment with immunosuppressive or cytotoxic medication the past year Pregnant women and patients aged less 18 years Patients with concomitant photosensitizing treatment Positive serology of herpes, HIV, hepatitis B and C

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm study<br>Dermabrasion with dermaroller of basal cell layer suspension obtained by soft trypsinisation in vitiligo lesion. | Device: Dermabrasion with dermaroller<br>* o The dermaroller is passed on the treated depigmented area. This technique is based on tiny microwounds performed using 540 microneedles (0.2mm length) which should allow the penetration of the suspension cells into the epidermis to obtain a good repigmentation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of repigmentation lesions | Image analysis | At 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global satisfaction expressed by the patient |  | At 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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derma-rolling system, vitiligo