Clinical trial NCT02156427: Evaluation of Non-cultured Epidermal Cellular Grafting vs Hyaluronic Acid for Repigmenting Vitiligo and Piebaldism
Official title: A Multicenter Double-blind Placebo-controlled Trial of Non-cultured Epidermal Cellular Grafting Versus Hyaluronic Acid for Repigmenting Stable Leukoderma (Vitiligo and Piebaldism)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vitiligo
Piebaldism
Lead sponsor: Laboratoires Genévrier
Sponsor class: INDUSTRY
First posted: 2014-06-05
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blind, prospective, multicenter, randomised, controlled trial patient is his own control
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of autologous epidermal cells suspension grafting using a newly developed device named VITICELL® compared to placebo.

The secondary objective is to evaluate safety of VITICELL® and global satisfaction of patient and investigator.


Eligibility criteria: Inclusion Criteria:

* Men and women aged over 18 years old with a diagnosis of non-scaring leukoderma that has been stable over the last 2 years (non-segmental, segmental vitiligo and piebaldism)
* For non-segmental vitiligo: symmetrical vitiligo lesions, or parts of a lesion. A part of at least 1 cm2 (1 x 1 cm), but preferable 4 cm2 (2x2 cm) and preferably in the center of each lesions (left/right) should be treated.

The minimum distance between the normal pigmented skin and the test area should preferably be at least 0.5 cm.

* For segmental vitiligo lesion and piebaldism: all lesions possible if two parts of at least 1 cm2 (1 x 1 cm), but preferably 4 cm2 (2 x 2 cm) in the lesion can be treated. The minimum distance between the 2 areas should be 2 cm and between test areas and to the normal pigmented skin preferably at least 0.5 cm.
* Medical treatments of vitiligo failed (in case of vitiligo: at least cream treatment for 6 months).
* Absence of infected lesion
* Negative serology (HIV-hepatitis B and C- Syphilis)
* Without treatment one month for cream and 3 months for phototherapy

Exclusion Criteria:

* Hypersensibility to local anaesthetics or one of the components of the device (trypsin, hyaluronic acid)
* Indication against biopsies
* Patient with a history of melanoma
* Positive serology (ongoing serious systemic disease, herpes, HIV, hepatitis B and C-Syphilis)
* Positive pregnancy test
* History of keloidal scars and presence of Koebner's phenomenon (type 1 and type 2b)
* Infected lesion
* Test areas not on fingers and toes vitiligo areas in case of non-segmental vitiligo
* Test areas not on facial non segmental vitiligo
* Pregnant women, or lactating
* Age \<18years
* Major deprived of their freedom by administrative or legal decision, or being the subject of a legal protection measure, or out of state to express their consent

Primary outcomes:
measure: Rate of successful repigmentation
timeFrame: at month 6
Secondary outcomes:
measure: Rate of successful repigmentation
timeFrame: at month 12
Other outcomes:
measure: Number of adverse events in each group
timeFrame: Day 0/Day 6-7/Month 3/6/9/12
measure: Mean reduction of treated area
timeFrame: Month 3/6/9/12
measure: Variation of area size
timeFrame: Day 0/Month 3/6/9/12
measure: Patient and physician satisfaction
timeFrame: Month12
Locations:
city: Ghent
country: Belgium
facility: Department of Dermatology - Ghent University Hospital
city: Bordeaux
country: France
facility: University Hospital Center of Bordeaux
city: Le Mans
country: France
facility: CHU Le Mans
city: Paris
country: France
facility: Dr Michel PASCAL
city: Roma
country: Italy
facility: San Gallicano Dermatological Institute
Study officials:
affiliation: Gent hospital
name: Nanja Van Geel, Pr
role: PRINCIPAL_INVESTIGATOR
References: