Transplantation of Basal Cell Layer Suspension Using Derma-rolling System in Vitiligo
Primary Purpose
Vitiligo
Status
Unknown status
Phase
Not Applicable
Locations
Morocco
Study Type
Interventional
Intervention
Dermabrasion with dermaroller
Sponsored by
About this trial
This is an interventional treatment trial for Vitiligo focused on measuring derma-rolling system, vitiligo
Eligibility 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
Sites / Locations
- Department of Dermatology, Ibn Sina University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single arm study
Arm Description
Dermabrasion with dermaroller of basal cell layer suspension obtained by soft trypsinisation in vitiligo lesion.
Outcomes
Primary Outcome Measures
Rate of repigmentation lesions
Image analysis
Secondary Outcome Measures
Global satisfaction expressed by the patient
Full Information
NCT ID
NCT02962180
First Posted
November 9, 2016
Last Updated
November 10, 2016
Sponsor
Mohammed V Souissi University
1. Study Identification
Unique Protocol Identification Number
NCT02962180
Brief Title
Transplantation of Basal Cell Layer Suspension Using Derma-rolling System in Vitiligo
Official Title
Transplantation With Dermarolling System of Basal Cell Layer Suspension Obtained by Soft Trypsinisation in Vitiligo Lesion
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mohammed V Souissi University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
To assess as control the effect of the use of dermaroller alone on the vitiligo lesion.
If transplantation is successful, to assess the duration needed to obtain a good coalescence and a complete repigmentation of the vitiligo lesion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
Keywords
derma-rolling system, vitiligo
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
single arm study
Arm Type
Experimental
Arm Description
Dermabrasion with dermaroller of basal cell layer suspension obtained by soft trypsinisation in vitiligo lesion.
Intervention Type
Device
Intervention Name(s)
Dermabrasion with dermaroller
Intervention Description
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 Measure Information:
Title
Rate of repigmentation lesions
Description
Image analysis
Time Frame
At 6 months
Secondary Outcome Measure Information:
Title
Global satisfaction expressed by the patient
Time Frame
At 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
laila benzekri, PhD
Phone
212671964111
Email
benzekrilaila@yahoo.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
laila benzekri
Organizational Affiliation
Mohammed V University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology, Ibn Sina University Hospital
City
Rabat
ZIP/Postal Code
10000
Country
Morocco
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LAILA BENZEKRI, PhD
Phone
212671964111
Email
benzekrilaila@yahoo.fr
First Name & Middle Initial & Last Name & Degree
YVON GAUTHIER, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20364383
Citation
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. Epub 2010 Apr 4.
Results Reference
result
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Transplantation of Basal Cell Layer Suspension Using Derma-rolling System in Vitiligo
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