Vitiligo
Conditions
Keywords
derma-rolling system, vitiligo
Brief summary
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
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 1. To assess as control the effect of the use of dermaroller alone on the vitiligo lesion. 2. If transplantation is successful, to assess the duration needed to obtain a good coalescence and a complete repigmentation of the vitiligo lesion.
Interventions
DEVICEDermabrasion with dermaroller
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.
Sponsors
Mohammed V Souissi University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of repigmentation lesions | At 6 months | Image analysis |
Secondary
| Measure | Time frame |
|---|---|
| Global satisfaction expressed by the patient | At 6 months |
Countries
Morocco
Contacts
Primary Contactlaila benzekri, PhD
Outcome results
None listed