Evaluation of Non-cultured Epidermal Cellular Grafting vs Hyaluronic Acid for Repigmenting Vitiligo and Piebaldism

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy of autologous epidermal cells suspension grafting using a newly developed device named VITICELL® compared to placebo. The secondary objective is to evaluate safety of VITICELL® and global satisfaction of patient and investigator.

Official Title
-----------------
A Multicenter Double-blind Placebo-controlled Trial of Non-cultured Epidermal Cellular Grafting Versus Hyaluronic Acid for Repigmenting Stable Leukoderma (Vitiligo and Piebaldism)

Conditions
-----------------
Vitiligo, Piebaldism

Intervention / Treatment
-----------------
* Device: VITICELL
* Device: PLACEBO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged over 18 years old with a diagnosis of non-scaring leukoderma that has been stable over the last 2 years (non-segmental, segmental vitiligo and piebaldism) For non-segmental vitiligo: symmetrical vitiligo lesions, or parts of a lesion. A part of at least 1 cm2 (1 x 1 cm), but preferable 4 cm2 (2x2 cm) and preferably in the center of each lesions (left/right) should be treated. The minimum distance between the normal pigmented skin and the test area should preferably be at least 0.5 cm. For segmental vitiligo lesion and piebaldism: all lesions possible if two parts of at least 1 cm2 (1 x 1 cm), but preferably 4 cm2 (2 x 2 cm) in the lesion can be treated. The minimum distance between the 2 areas should be 2 cm and between test areas and to the normal pigmented skin preferably at least 0.5 cm. Medical treatments of vitiligo failed (in case of vitiligo: at least cream treatment for 6 months). Absence of infected lesion Negative serology (HIV-hepatitis B and C- Syphilis) Without treatment one month for cream and 3 months for phototherapy Exclusion Criteria: Hypersensibility to local anaesthetics or one of the components of the device (trypsin, hyaluronic acid) Indication against biopsies Patient with a history of melanoma Positive serology (ongoing serious systemic disease, herpes, HIV, hepatitis B and C-Syphilis) Positive pregnancy test History of keloidal scars and presence of Koebner's phenomenon (type 1 and type 2b) Infected lesion Test areas not on fingers and toes vitiligo areas in case of non-segmental vitiligo Test areas not on facial non segmental vitiligo Pregnant women, or lactating Age <18years Major deprived of their freedom by administrative or legal decision, or being the subject of a legal protection measure, or out of state to express their consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double-blind, prospective, multicenter, randomised, controlled trial patient is his own control
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VITICELL<br>In this arm, lesions will be treated by autologous epidermal cells suspension (containing hyaluronic acid) obtained after VITICELL kit's use, a class III medical device. | Device: VITICELL<br>* graft of autologus cells (kaeratonicytes and melanocytes) obtained after trypsinization of thin skin biopsy resuspended into hyaluronic acid<br>|
| Placebo Comparator: PLACEBO<br>In this arm, lesions will be treated by a suspension of hyaluronic acid without epidermal cells. | Device: PLACEBO<br>* hyaluronic acid alone<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful repigmentation | succesful repigementation define as more than or equal to 50% repigmentation of the treated area | at month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful repigmentation | succesful repigementation define as more than or equal to 50% repigmentation of the treated area | at month 12 |