Evaluation of Non-cultured Epidermal Cellular Grafting vs Hyaluronic Acid for Repigmenting Vitiligo and Piebaldism

Laboratoires Genévrier

Status and phase: Completed; Phase 3

Conditions: Piebaldism; Vitiligo

Treatments: Device: PLACEBO; Device: VITICELL

Study type: Interventional

Funder types: Industry

Identifiers

NCT02156427

13INT/VIT01

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups, including a placebo group

VITICELL

Experimental group

Description:

In this arm, lesions will be treated by autologous epidermal cells suspension (containing hyaluronic acid) obtained after VITICELL kit's use, a class III medical device.

Treatment:

Device: VITICELL

PLACEBO

Placebo Comparator group

Description:

In this arm, lesions will be treated by a suspension of hyaluronic acid without epidermal cells.

Treatment:

Device: PLACEBO