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

Not Applicable

• Conditions: Vitiligo
• Interventions: Device: Dermabrasion with dermaroller

• Registration Number: NCT02962180
• Lead Sponsor: Mohammed V Souissi University

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.

Study Timeline

• Study Start: 2016-03
• Status Verified: 2016-11
• Primary Completion: 2016-11
• Study First Submitted: 2016-11-09
• Study First Submitted QC: 2016-11-10
• Last Update Submitted: 2016-11-10
• Study First Posted: 2016-11-11
• Last Update Posted: 2016-11-11
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm study	Dermabrasion with dermaroller	Dermabrasion with dermaroller of basal cell layer suspension obtained by soft trypsinisation in vitiligo lesion.

Primary Outcome Measures

Name	Time	Method
Rate of repigmentation lesions	At 6 months	Image analysis

Secondary Outcome Measures

Name	Time	Method
Global satisfaction expressed by the patient	At 6 months

Trial Locations

Locations (1)

Department of Dermatology, Ibn Sina University Hospital; 🇲🇦 Rabat, Morocco