Effect of Procedural Variables on Outcome of Surgical Treatment of Vitiligo

NCT ID: NCT02510651

Last Updated: 2015-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Vitiligo

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ORSHFS

Melanocyte-keratinocyte suspension.

Group Type EXPERIMENTAL

Melanocyte-keratinocyte suspension

Intervention Type PROCEDURE

Treatment of non-segmental vitiligo by CO2 laser followed by melanocyte-keratinocyte suspension.

Interventions

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Melanocyte-keratinocyte suspension

Treatment of non-segmental vitiligo by CO2 laser followed by melanocyte-keratinocyte suspension.

Intervention Type PROCEDURE

Other Intervention Names

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CO2 laser

Eligibility Criteria

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Inclusion Criteria

* Stable non-segmental vitiligo

Exclusion Criteria

* Active vitiligo
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Dalia Abdel Halim

Assisstant professorof dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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DAH555

Identifier Type: -

Identifier Source: org_study_id

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