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

Vitiligo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02962180
• Other study ID #: MOHAMMED V UNIVERSITY
• Status: Recruiting
• Phase: N/A
• First received: November 9, 2016
• Last updated: November 10, 2016
• Start date: March 2016
• Est. completion date: December 2017

Study information

• Verified date: November 2016
• Source: Mohammed V Souissi University
• Contact: laila benzekri, PhD
• Phone: 212671964111
• Email: benzekrilaila[@]yahoo.fr
• Is FDA regulated: No
• Health authority: Morocco: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitiligo

Intervention

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.

Locations

Country	Name	City	State
Morocco	Department of Dermatology, Ibn Sina University Hospital	Rabat

Sponsors (1)

Lead Sponsor	Collaborator
Mohammed V Souissi University

Country where clinical trial is conducted

Morocco, 

References & Publications (1)

Khodadadi L, Shafieyan S, Sotoudeh M, Dizaj AV, Shahverdi A, Aghdami N, Baharvand H. Intraepidermal injection of dissociated epidermal cell suspension improves vitiligo. Arch Dermatol Res. 2010 Oct;302(8):593-9. doi: 10.1007/s00403-010-1034-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of repigmentation lesions	Image analysis	At 6 months	No
Secondary	Global satisfaction expressed by the patient		At 6 months	No