Effect of Procedural Variables on Outcome of Surgical Treatment of Vitiligo
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|ClinicalTrials.gov Identifier: NCT02510651|
Recruitment Status : Completed
First Posted : July 29, 2015
Last Update Posted : July 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Vitiligo||Procedure: Melanocyte-keratinocyte suspension||Phase 1|
Background: Melanocyte-keratinocyte suspension (M-K susp) is gaining popularity for vitiligo treatment. Few studies have addressed procedure-related variables.
Objective: To assess the effect of different M-K susp procedure-related variables on the clinical outcome in stable vitiligo.
Methods: This retrospective study included 40 cases with stable non-segmental vitiligo treated by M-K susp followed by narrow band- ultraviolet B phototherapy twice weekly. Donor site was either a skin graft in non-cultured epidermal cell suspension (NCECS) (34 cases) or hair follicle unit in Outer Root Sheath Hair Follicle Suspension (ORSHFS) (6 cases). Recipient site was prepared by either cryoblebbing (24 cases) or carbon dioxide (CO2)laser resurfacing (16 cases). Cell counts and viability were recorded in the cell suspensions, and tissue melanocytes and keratinocytes were examined by Melan A and Cytokeratin respectively. Assessment of repigmentation was done 18 months after the procedure.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Procedural-Related Variables on Melanocyte-Keratinocyte Suspension Transplantation in Non-Segmental Stable Vitiligo: A Clinical and Immunohistochemical Study|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||June 2014|
Procedure: Melanocyte-keratinocyte suspension
Treatment of non-segmental vitiligo by CO2 laser followed by melanocyte-keratinocyte suspension.
Other Name: CO2 laser
- The number of patients with satisfactory response after the surgical procedure for vitiligo. [ Time Frame: one year ]