Effect of Procedural Variables on Outcome of Surgical Treatment of Vitiligo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02510651
Recruitment Status : Completed
First Posted : July 29, 2015
Last Update Posted : July 29, 2015
Information provided by (Responsible Party):
Dalia Abdel Halim, 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.

Condition or disease Intervention/treatment Phase
Vitiligo Procedure: Melanocyte-keratinocyte suspension Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo

Arm Intervention/treatment
Experimental: ORSHFS
Melanocyte-keratinocyte suspension.
Procedure: Melanocyte-keratinocyte suspension
Treatment of non-segmental vitiligo by CO2 laser followed by melanocyte-keratinocyte suspension.
Other Name: CO2 laser

Primary Outcome Measures :
  1. The number of patients with satisfactory response after the surgical procedure for vitiligo. [ Time Frame: one year ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Stable non-segmental vitiligo

Exclusion Criteria:

  • Active vitiligo

Responsible Party: Dalia Abdel Halim, Assisstant professorof dermatology, Cairo University Identifier: NCT02510651     History of Changes
Other Study ID Numbers: DAH555
First Posted: July 29, 2015    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015

Keywords provided by Dalia Abdel Halim, Cairo University:
: non-segmental vitiligo
melanocyte-keratinocyte suspension
CO2 laser

Additional relevant MeSH terms:
Pigmentation Disorders
Skin Diseases