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

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ClinicalTrials.gov Identifier: NCT02962180
Recruitment Status : Unknown
Verified November 2016 by BENZEKRI LAILA, Mohammed V Souissi University.
Recruitment status was:  Recruiting
First Posted : November 11, 2016
Last Update Posted : November 11, 2016
Sponsor:
Information provided by (Responsible Party):
BENZEKRI LAILA, 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.

Condition or disease Intervention/treatment Phase
Vitiligo Device: Dermabrasion with dermaroller Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transplantation With Dermarolling System of Basal Cell Layer Suspension Obtained by Soft Trypsinisation in Vitiligo Lesion
Study Start Date : March 2016
Actual Primary Completion Date : November 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo

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.




Primary Outcome Measures :
  1. Rate of repigmentation lesions [ Time Frame: At 6 months ]
    Image analysis


Secondary Outcome Measures :
  1. Global satisfaction expressed by the patient [ Time Frame: At 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02962180


Contacts
Contact: laila benzekri, PhD 212671964111 benzekrilaila@yahoo.fr

Locations
Morocco
Department of Dermatology, Ibn Sina University Hospital Recruiting
Rabat, Morocco, 10000
Contact: LAILA BENZEKRI, PhD    212671964111    benzekrilaila@yahoo.fr   
Sub-Investigator: YVON GAUTHIER, MD         
Sponsors and Collaborators
Mohammed V Souissi University
Investigators
Principal Investigator: laila benzekri Mohammed V University

Publications of Results:
Responsible Party: BENZEKRI LAILA, PhD, Mohammed V Souissi University
ClinicalTrials.gov Identifier: NCT02962180     History of Changes
Other Study ID Numbers: MOHAMMED V UNIVERSITY
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by BENZEKRI LAILA, Mohammed V Souissi University:
derma-rolling system, vitiligo

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases