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

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

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.

Study Overview

• Status: Completed
• Conditions: Vitiligo; Piebaldism
• Intervention / Treatment: Device: VITICELL; Device: PLACEBO

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium
    • Department of Dermatology - Ghent University Hospital
• France
  • Bordeaux, France
    • UNIVERSITY HOSPITAL CENTER of Bordeaux
  • Le Mans, France
    • CHU Le Mans
  • Paris, France
    • Dr Michel PASCAL
• Italy
  • Roma, Italy
    • San Gallicano Dermatological Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VITICELL; 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.	Device: VITICELL; graft of autologus cells (kaeratonicytes and melanocytes) obtained after trypsinization of thin skin biopsy resuspended into hyaluronic acid
Placebo Comparator: PLACEBO; In this arm, lesions will be treated by a suspension of hyaluronic acid without epidermal cells.	Device: PLACEBO; hyaluronic acid alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of successful repigmentation	succesful repigementation define as more than or equal to 50% repigmentation of the treated area	at month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of successful repigmentation	succesful repigementation define as more than or equal to 50% repigmentation of the treated area	at month 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events in each group		Day 0/Day 6-7/Month 3/6/9/12
Mean reduction of treated area	calculated in pourcentage from baseline	Month 3/6/9/12
Variation of area size	Size in cm² measured at each visit	Day 0/Month 3/6/9/12
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

Collaborators and Investigators

• Sponsor: Laboratoires Genévrier
• Investigators: Principal Investigator: Nanja Van Geel, Pr, Gent hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2014
• Primary Completion (Actual): April 10, 2018
• Study Completion (Actual): April 10, 2018

Study Registration Dates

• First Submitted: May 30, 2014
• First Submitted That Met QC Criteria: June 4, 2014
• First Posted (Estimate): June 5, 2014

Study Record Updates

• Last Update Posted (Actual): October 14, 2019
• Last Update Submitted That Met QC Criteria: October 10, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Skin Diseases; Genetic Diseases, Inborn; Skin Diseases, Genetic; Eye Diseases, Hereditary; Metabolism, Inborn Errors; Amino Acid Metabolism, Inborn Errors; Pigmentation Disorders; Hypopigmentation; Albinism; Vitiligo; Piebaldism
• Other Study ID Numbers: 13INT/VIT01