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Effect of Procedural Variables on Outcome of Surgical Treatment of Vitiligo

Primary Purpose

Vitiligo

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Melanocyte-keratinocyte suspension
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo focused on measuring : non-segmental vitiligo, melanocyte-keratinocyte suspension, cryoblebbing, CO2 laser

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stable non-segmental vitiligo

Exclusion Criteria:

  • Active vitiligo

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    ORSHFS

    Arm Description

    Melanocyte-keratinocyte suspension.

    Outcomes

    Primary Outcome Measures

    The number of patients with satisfactory response after the surgical procedure for vitiligo.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 22, 2015
    Last Updated
    July 28, 2015
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02510651
    Brief Title
    Effect of Procedural Variables on Outcome of Surgical Treatment of Vitiligo
    Official Title
    Effect of Procedural-Related Variables on Melanocyte-Keratinocyte Suspension Transplantation in Non-Segmental Stable Vitiligo: A Clinical and Immunohistochemical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    January 2014 (Actual)
    Study Completion Date
    June 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vitiligo
    Keywords
    : non-segmental vitiligo, melanocyte-keratinocyte suspension, cryoblebbing, CO2 laser

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ORSHFS
    Arm Type
    Experimental
    Arm Description
    Melanocyte-keratinocyte suspension.
    Intervention Type
    Procedure
    Intervention Name(s)
    Melanocyte-keratinocyte suspension
    Other Intervention Name(s)
    CO2 laser
    Intervention Description
    Treatment of non-segmental vitiligo by CO2 laser followed by melanocyte-keratinocyte suspension.
    Primary Outcome Measure Information:
    Title
    The number of patients with satisfactory response after the surgical procedure for vitiligo.
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Stable non-segmental vitiligo Exclusion Criteria: Active vitiligo

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Procedural Variables on Outcome of Surgical Treatment of Vitiligo

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