Transplantation of Basal Cell Layer Suspension Using Derma-rolling System in Vitiligo
NCT ID: NCT02962180
Last Updated: 2016-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
10 participants
INTERVENTIONAL
2016-03-31
2017-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
single arm study
Dermabrasion with dermaroller of basal cell layer suspension obtained by soft trypsinisation in vitiligo lesion.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Men and women aged over 18 years of age
* The lesion area must be 2cm2\< lesion\< 15cm2
* Absence of infected lesion
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mohammed V Souissi University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
BENZEKRI LAILA
PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
laila benzekri
Role: PRINCIPAL_INVESTIGATOR
Mohammed V University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Dermatology, Ibn Sina University Hospital
Rabat, Morocco, Morocco
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
LAILA BENZEKRI, PhD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MOHAMMED V UNIVERSITY
Identifier Type: -
Identifier Source: org_study_id