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

Vitiligo Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02156427
• Other study ID #: 13INT/VIT01
• Status: Completed
• Phase: Phase 3
• Start date: April 29, 2014
• Est. completion date: April 10, 2018

Study information

• Verified date: October 2019
• Source: Laboratoires Genévrier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 10, 2018
• Est. primary completion date: April 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Piebaldism
• Vitiligo

Intervention

Device:
• VITICELL
graft of autologus cells (kaeratonicytes and melanocytes) obtained after trypsinization of thin skin biopsy resuspended into hyaluronic acid
• PLACEBO
hyaluronic acid alone

Locations

Country	Name	City	State
Belgium	Department of Dermatology - Ghent University Hospital	Ghent
France	University Hospital Center of Bordeaux	Bordeaux
France	CHU Le Mans	Le Mans
France	Dr Michel PASCAL	Paris
Italy	San Gallicano Dermatological Institute	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Genévrier

Countries where clinical trial is conducted

Belgium,  France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of adverse events in each group		Day 0/Day 6-7/Month 3/6/9/12
Other	Mean reduction of treated area	calculated in pourcentage from baseline	Month 3/6/9/12
Other	Variation of area size	Size in cm² measured at each visit	Day 0/Month 3/6/9/12
Other	Patient and physician satisfaction	Likert scale ranging from 1 to 5 (1=Not at all satisfied / 2=Slightly satisfied / 3=Moderately satisfied / 4=Very satisfied / 5=Extremely satisfied).	Month12
Primary	Rate of successful repigmentation	succesful repigementation define as more than or equal to 50% repigmentation of the treated area	at month 6
Secondary	Rate of successful repigmentation	succesful repigementation define as more than or equal to 50% repigmentation of the treated area	at month 12