Transplantation of Basal Cell Layer Suspension Using Derma-rolling System in Vitiligo
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|ClinicalTrials.gov Identifier: NCT02962180|
Recruitment Status : Recruiting
First Posted : November 11, 2016
Last Update Posted : November 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Vitiligo||Device: Dermabrasion with dermaroller||Not Applicable|
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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Rate of repigmentation lesions [ Time Frame: At 6 months ]Image analysis
- Global satisfaction expressed by the patient [ Time Frame: At 6 months ]
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
|Contact: laila benzekri, PhDfirstname.lastname@example.org|
|Department of Dermatology, Ibn Sina University Hospital||Recruiting|
|Rabat, Morocco, 10000|
|Contact: LAILA BENZEKRI, PhD 212671964111 email@example.com|
|Sub-Investigator: YVON GAUTHIER, MD|
|Principal Investigator:||laila benzekri||Mohammed V University|