Clinical trial NCT01629979: Epidermal Cell Transplantation in Vitiligo Skin
Official title: Efficacy and Tolerance of Transplantation of Harvested Epidermal Cells and Narrow-Band UVB in Vitiligo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: VITILIGO
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2012-06-28
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Repigmentation rate at 12 months
timeFrame: 12months
Secondary outcomes:
measure: Repigmentation > 70% at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre hospitalier Universitaire de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: philippe bahadoran, doctor
role: PRINCIPAL_INVESTIGATOR
References: