Epidermal Cell Transplantation in Vitiligo Skin (VITICELL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01629979
First received: March 23, 2012
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

The effects of treatment of transplantation of harvested autologous epidermal cells on vitiligo lesions followed by narrow-band UVB will be investigated in a randomized controlled study.


Condition Intervention Phase
VITILIGO
Procedure: Grafting with epidermal cells
Radiation: UVB treatment
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Tolerance of Transplantation of Harvested Epidermal Cells and Narrow-Band UVB in Vitiligo

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • Repigmentation rate at 12 months [ Time Frame: 12months ] [ Designated as safety issue: No ]
    Repigmentation rate at 12 months


Secondary Outcome Measures:
  • Repigmentation > 70% at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Repigmentation > 70% at 12 months


Enrollment: 23
Study Start Date: May 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: Grafting of autologous epidermal harvested cells and UVB

Grafting with epidermal cells: A superficial skin shaving excision will be obtained from pigmented skin using a dermatome. A cell suspension will be obtained by trypsinisation. Vitiligo skin will be dermabraded by Erbium: Yag laser after local anaesthesia. The cell suspension will be spread on the dermabraded skin area and fixed with dressings. Keratinocyte, and melanocyte counts will be performed on an aliquot of the cell suspension. One symmetrical patch of vitiligo will be chosen as control and left untreated.

Narrow-band UVB treatment: Four weeks after transplantation of epidermal cells, the grafted and control patch will be treated by Narrow-band UVB. Treatment will be performed 2 times a week. Narrow-band UVB treatment will be performed for at least 3 months or 24 treatments.

Procedure: Grafting with epidermal cells

A superficial skin shaving excision will be obtained from pigmented skin using a dermatome. A cell suspension will be obtained by trypsinisation. Vitiligo skin will be dermabraded by Erbium: Yag laser after local anaesthesia. The cell suspension will be spread on the dermabraded skin area and fixed with dressings. Keratinocyte, and melanocyte counts will be performed on an aliquot of the cell suspension. One symmetrical patch of vitiligo will be chosen as control and left untreated.

Narrow-band UVB treatment: Four weeks after transplantation of epidermal cells, the grafted and control patch will be treated by Narrow-band UVB. Treatment will be performed 2 times a week. Narrow-band UVB treatment will be performed for at least 3 months or 24 treatments.

Active Comparator: UVB treatment
UVB treatment twice a week during 3months
Radiation: UVB treatment
the control patch will be treated by Narrow-band UVB. Treatment will be performed 2 times a week. Narrow-band UVB treatment will be performed for at least 3 months or 24 treatments.

Detailed Description:

Introduction: Transplantation of harvested autologous epidermal cells in vitiligo is widely used in vitiligo but randomized controlled trials in the literature investigating the efficacy of these noncultured keratinocyte/melanocyte suspensions are scarce. In addition there are few data regarding the relationship between the cellular contents of epidermal suspensions and the clinical outcome.

Aim of the study: To perform a prospective, controlled, randomized, intra-individual comparative study in vitiligo lesions treated with epidermal cell transplantation with additional narrow-band UVB treatment using epidermal cell suspensions that have been characterized at the cellular level.

Study design:

Grafting with epidermal cells: A superficial skin shaving excision will be obtained from pigmented skin using a dermatome. A cell suspension will be obtained by trypsinisation. Vitiligo skin will be dermabraded by Erbium: Yag laser after local anaesthesia. The cell suspension will be spread on the dermabraded skin area and fixed with dressings. Keratinocyte, and melanocyte counts will be performed on an aliquot of the cell suspension. One symmetrical patch of vitiligo will be chosen as control and left untreated.

Narrow-band UVB treatment: Four weeks after transplantation of epidermal cells, the grafted and control patch will be treated by Narrow-band UVB. Treatment will be performed 2 times a week. Narrow-band UVB treatment will be performed for at least 3 months or 24 treatments.

Evaluation of the treatment success: The grade of pigmentation in all lesions will be evaluated clinically, with photographs. The clinical rating will be performed as follows: 0 = no repigmentation; 1 = 1-25% repigmentation; 2 = 26 to 50% repigmentation; 3 = 51 to 75% repigmentation; and 4 = 76 to 100% repigmentation. The evaluation of the photographs will be performed blinded by physicians not engaged in the treatment phase of the study. In addition the surface of vitiligo patches will be traced on transparent sheets and monitored by planimetry.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18yr
  • Stable vitiligo (no lesion since 12 mo)
  • 2 symmetrical vitiligo patches of at least 10 cm2
  • Vitiligo requiring UVB treatment
  • Women using a contraceptive

Exclusion Criteria:

  • History of keloids
  • History of skin cancer
  • Photosensitivity
  • Positive blood test for HIV, HBV, HVC, or HTLV1
  • Pregnant or breastfeeding women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01629979

Locations
France
Centre hospitalier Universitaire de Nice
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: philippe bahadoran, doctor Centre Hospitalier Universitaire de Nice
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01629979     History of Changes
Other Study ID Numbers: 2010-018886-52
Study First Received: March 23, 2012
Last Updated: May 29, 2013
Health Authority: France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014