Clinical Trials/NCT02510651

NCT02510651CompletedPhase 1

Effect of Procedural-Related Variables on Melanocyte-Keratinocyte Suspension Transplantation in Non-Segmental Stable Vitiligo: A Clinical and Immunohistochemical Study

Cairo University0 sites40 target enrollmentStarted: January 2010Last updated: July 29, 2015

Conditions

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor: Cairo University
Enrollment: 40
Primary Endpoint: The number of patients with satisfactory response after the surgical procedure for vitiligo.

Study Overview Study Design Eligibility Criteria Outcomes Investigators Records & Identifiers Similar Trials

Study Overview

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 Design

Study Type: Interventional
Allocation: Na
Intervention Model: Single Group
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•Stable non-segmental vitiligo

Exclusion Criteria

•Active vitiligo

Outcomes

Primary Outcomes

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

Time Frame: one year

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor

Cairo University

Sponsor Class

Other

Responsible Party

Principal Investigator

Dalia Abdel Halim

Assisstant professorof dermatology

Cairo University

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