Transplantation of Basal Cell Layer Suspension Using Derm... | NCT02962180

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

NCT02962180

Sponsor

Mohammed V Souissi University

Status

Unknown status

Last Update Posted

Nov 11, 2016Estimated

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Vitiligo

Interventions

Dermabrasion with dermaroller

Countries

Morocco

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Nov 2016Actual

Completion Date

Dec 2017Estimated

First Submitted Date

Nov 9, 2016

First Submission Date that Met QC Criteria

Nov 10, 2016

First Posted Date

Nov 11, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 10, 2016

Last Update Posted Date

Nov 11, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

BENZEKRI LAILA, PhD, Mohammed V Souissi UniversityPrincipal Investigator

Lead Sponsor

Mohammed V Souissi UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
single arm study	Experimental	Dermabrasion with dermaroller of basal cell layer suspension obtained by soft trypsinisation in vitiligo lesion.	Device: Dermabrasion with dermaroller

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dermabrasion with dermaroller	Device	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
laila benzekri, PhD	Contact	212671964111		benzekrilaila@yahoo.fr

Overall Officials

Name	Affiliation	Role
laila benzekri	Mohammed V University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Dermatology, Ibn Sina University Hospital	Recruiting	Rabat	Morocco	10000	Morocco

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20364383	Result	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.

ID	Term
D017496	Hypopigmentation
D010859	Pigmentation Disorders
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D003357	Cosmetic Techniques
D013812	Therapeutics
D062109	Dermatologic Surgical Procedures
D019651	Plastic Surgery Procedures