search
Back to results

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

Primary Purpose

Vitiligo, Piebaldism

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
VITICELL
PLACEBO
Sponsored by
Laboratoires Genévrier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Dermatology - Ghent University Hospital
  • University Hospital Center of Bordeaux
  • CHU Le Mans
  • Dr Michel PASCAL
  • San Gallicano Dermatological Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VITICELL

PLACEBO

Arm 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.

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

Outcomes

Primary Outcome Measures

Rate of successful repigmentation
succesful repigementation define as more than or equal to 50% repigmentation of the treated area

Secondary Outcome Measures

Rate of successful repigmentation
succesful repigementation define as more than or equal to 50% repigmentation of the treated area

Full Information

First Posted
May 30, 2014
Last Updated
October 10, 2019
Sponsor
Laboratoires Genévrier
search

1. Study Identification

Unique Protocol Identification Number
NCT02156427
Brief Title
Evaluation of Non-cultured Epidermal Cellular Grafting vs Hyaluronic Acid for Repigmenting Vitiligo and Piebaldism
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 29, 2014 (Actual)
Primary Completion Date
April 10, 2018 (Actual)
Study Completion Date
April 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoires Genévrier

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo, Piebaldism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
double-blind, prospective, multicenter, randomised, controlled trial patient is his own control
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VITICELL
Arm Type
Experimental
Arm 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.
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
In this arm, lesions will be treated by a suspension of hyaluronic acid without epidermal cells.
Intervention Type
Device
Intervention Name(s)
VITICELL
Intervention Description
graft of autologus cells (kaeratonicytes and melanocytes) obtained after trypsinization of thin skin biopsy resuspended into hyaluronic acid
Intervention Type
Device
Intervention Name(s)
PLACEBO
Intervention Description
hyaluronic acid alone
Primary Outcome Measure Information:
Title
Rate of successful repigmentation
Description
succesful repigementation define as more than or equal to 50% repigmentation of the treated area
Time Frame
at month 6
Secondary Outcome Measure Information:
Title
Rate of successful repigmentation
Description
succesful repigementation define as more than or equal to 50% repigmentation of the treated area
Time Frame
at month 12
Other Pre-specified Outcome Measures:
Title
Number of adverse events in each group
Time Frame
Day 0/Day 6-7/Month 3/6/9/12
Title
Mean reduction of treated area
Description
calculated in pourcentage from baseline
Time Frame
Month 3/6/9/12
Title
Variation of area size
Description
Size in cm² measured at each visit
Time Frame
Day 0/Month 3/6/9/12
Title
Patient and physician satisfaction
Description
Likert scale ranging from 1 to 5 (1=Not at all satisfied / 2=Slightly satisfied / 3=Moderately satisfied / 4=Very satisfied / 5=Extremely satisfied).
Time Frame
Month12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nanja Van Geel, Pr
Organizational Affiliation
Gent hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology - Ghent University Hospital
City
Ghent
Country
Belgium
Facility Name
University Hospital Center of Bordeaux
City
Bordeaux
Country
France
Facility Name
CHU Le Mans
City
Le Mans
Country
France
Facility Name
Dr Michel PASCAL
City
Paris
Country
France
Facility Name
San Gallicano Dermatological Institute
City
Roma
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs