Evaluation of Non-cultured Epidermal Cellular Grafting vs... | NCT02156427

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

NCT02156427

Sponsor

Laboratoires Genévrier

Status

Completed

Last Update Posted

Oct 14, 2019Actual

Enrollment

38Actual

Phase

Phase 3

Conditions

Vitiligo
Piebaldism

Interventions

VITICELL
PLACEBO

Countries

Belgium
France
Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 29, 2014Actual

Primary Completion Date

Apr 10, 2018Actual

Completion Date

Apr 10, 2018Actual

First Submitted Date

May 30, 2014

First Submission Date that Met QC Criteria

Jun 4, 2014

First Posted Date

Jun 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2019

Last Update Posted Date

Oct 14, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VITICELL	Experimental	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
PLACEBO	Placebo Comparator	In this arm, lesions will be treated by a suspension of hyaluronic acid without epidermal cells.	Device: PLACEBO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VITICELL	Device	graft of autologus cells (kaeratonicytes and melanocytes) obtained after trypsinization of thin skin biopsy resuspended into hyaluronic acid	VITICELL

Outcomes Module

Primary Outcomes

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 Outcomes

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 Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Department of Dermatology - Ghent University Hospital		Ghent			Belgium
University Hospital Center of Bordeaux

ID	Term
D017496	Hypopigmentation
D010859	Pigmentation Disorders
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D014820	Vitiligo
D016116	Piebaldism