Effect of Procedural Variables on Outcome of Surgical Treatment of Vitiligo

Phase 1

Completed

• Conditions: Vitiligo
• Interventions: Procedure: Melanocyte-keratinocyte suspension

• Registration Number: NCT02510651
• Lead Sponsor: Cairo University

Brief Summary

ORSHFS grafts yielded lower cell counts than NCECS but the M-K ratio and resultant repigmentation did not show significant difference with better healing of the donor site. Compared to cryoblebs, CO2 gave more homogenous pigmentation. The acral sites showed better results using combination of donor NCECS and recipient cryoblebs.

Detailed Description

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 Timeline

• Study Start: 2010-01
• Primary Completion: 2014-01
• Study Completion: 2014-06
• Status Verified: 2015-07
• Study First Submitted: 2015-07-22
• Study First Submitted QC: 2015-07-28
• Last Update Submitted: 2015-07-28
• Study First Posted: 2015-07-29
• Last Update Posted: 2015-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Stable non-segmental vitiligo

Exclusion Criteria

• Active vitiligo

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ORSHFS	Melanocyte-keratinocyte suspension	Melanocyte-keratinocyte suspension.

Primary Outcome Measures

Name	Time	Method
The number of patients with satisfactory response after the surgical procedure for vitiligo.	one year