Piebaldism, Vitiligo
Conditions
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.
Interventions
DEVICEVITICELL
graft of autologus cells (kaeratonicytes and melanocytes) obtained after trypsinization of thin skin biopsy resuspended into hyaluronic acid
DEVICEPLACEBO
hyaluronic acid alone
Sponsors
Laboratoires Genévrier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
double-blind, prospective, multicenter, randomised, controlled trial patient is his own control
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of successful repigmentation | at month 6 | succesful repigementation define as more than or equal to 50% repigmentation of the treated area |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of successful repigmentation | at month 12 | succesful repigementation define as more than or equal to 50% repigmentation of the treated area |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events in each group | Day 0/Day 6-7/Month 3/6/9/12 | — |
| Mean reduction of treated area | Month 3/6/9/12 | calculated in pourcentage from baseline |
| Variation of area size | Day 0/Month 3/6/9/12 | Size in cm² measured at each visit |
| Patient and physician satisfaction | Month12 | Likert scale ranging from 1 to 5 (1=Not at all satisfied / 2=Slightly satisfied / 3=Moderately satisfied / 4=Very satisfied / 5=Extremely satisfied). |
Countries
Belgium, France, Italy
Outcome results
None listed