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

Sponsor
Laboratoires Genévrier (Industry)
Overall Status
Completed
CT.gov ID
NCT02156427
Collaborator
(none)
38
Enrollment
5
Locations
2
Arms
47.4
Actual Duration (Months)
7.6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: VITICELL
  • Device: PLACEBO
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
double-blind, prospective, multicenter, randomised, controlled trial patient is his own controldouble-blind, prospective, multicenter, randomised, controlled trial patient is his own control
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Apr 29, 2014
Actual Primary Completion Date :
Apr 10, 2018
Actual Study Completion Date :
Apr 10, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Rate of successful repigmentation [at month 6]

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

Secondary Outcome Measures

  1. Rate of successful repigmentation [at month 12]

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

Other Outcome Measures

  1. Number of adverse events in each group [Day 0/Day 6-7/Month 3/6/9/12]

  2. Mean reduction of treated area [Month 3/6/9/12]

    calculated in pourcentage from baseline

  3. Variation of area size [Day 0/Month 3/6/9/12]

    Size in cm² measured at each visit

  4. Patient and physician satisfaction [Month12]

    Likert scale ranging from 1 to 5 (1=Not at all satisfied / 2=Slightly satisfied / 3=Moderately satisfied / 4=Very satisfied / 5=Extremely satisfied).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Dermatology - Ghent University Hospital Ghent Belgium
2 University Hospital Center of Bordeaux Bordeaux France
3 CHU Le Mans Le Mans France
4 Dr Michel PASCAL Paris France
5 San Gallicano Dermatological Institute Roma Italy

Sponsors and Collaborators

  • Laboratoires Genévrier

Investigators

  • Principal Investigator: Nanja Van Geel, Pr, Gent hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Laboratoires Genévrier
ClinicalTrials.gov Identifier:
NCT02156427
Other Study ID Numbers:
  • 13INT/VIT01
First Posted:
Jun 5, 2014
Last Update Posted:
Oct 14, 2019
Last Verified:
Oct 1, 2019
Additional relevant MeSH terms:
Piebaldism
Vitiligo

Study Results

No Results Posted as of Oct 14, 2019