A Multicenter Double-blind Placebo-controlled Trial of Non-cultured Epidermal Cellular Grafting Versus Hyaluronic Acid for Repigmenting Stable Leukoderma (Vitiligo and Piebaldism)

Laboratoires Genévrier5 sites in 3 countries38 target enrollmentApril 29, 2014

ConditionsVitiligo Piebaldism

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Vitiligo
Sponsor: Laboratoires Genévrier
Enrollment: 38
Locations: 5
Primary Endpoint: Rate of successful repigmentation
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 29, 2014

End Date

April 10, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Laboratoires Genévrier

Responsible Party

Sponsor

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