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

November 10, 2016 updated by: BENZEKRI LAILA, Mohammed V Souissi University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Morocco
      • Rabat, Morocco, 10000
        • Recruiting
        • Department of Dermatology, Ibn Sina University Hospital
        • Contact:
        • Sub-Investigator:
          • YVON GAUTHIER, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single arm study
Dermabrasion with dermaroller of basal cell layer suspension obtained by soft trypsinisation in vitiligo lesion.
Device: Dermabrasion 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Global satisfaction expressed by the patient
Time Frame: At 6 months
At 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohammed V Souissi University

Investigators

  • Principal Investigator: laila benzekri, Mohammed V University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

November 9, 2016

First Submitted That Met QC Criteria

November 10, 2016

First Posted (Estimate)

November 11, 2016

Study Record Updates

Last Update Posted (Estimate)

November 11, 2016

Last Update Submitted That Met QC Criteria

November 10, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOHAMMED V UNIVERSITY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

Subscribe