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

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ClinicalTrials.gov Identifier: NCT02156427
Recruitment Status : Completed
First Posted : June 5, 2014
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Laboratoires Genévrier

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
Vitiligo Piebaldism Device: VITICELL Device: PLACEBO Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double-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 : April 29, 2014
Actual Primary Completion Date : April 10, 2018
Actual Study Completion Date : April 10, 2018


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




Primary Outcome Measures :
  1. Rate of successful repigmentation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 0/Day 6-7/Month 3/6/9/12 ]
  2. Mean reduction of treated area [ Time Frame: Month 3/6/9/12 ]
    calculated in pourcentage from baseline

  3. Variation of area size [ Time Frame: Day 0/Month 3/6/9/12 ]
    Size in cm² measured at each visit

  4. Patient and physician satisfaction [ Time Frame: 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02156427


Locations
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Belgium
Department of Dermatology - Ghent University Hospital
Ghent, Belgium
France
University Hospital Center of Bordeaux
Bordeaux, France
CHU Le Mans
Le Mans, France
Dr Michel PASCAL
Paris, France
Italy
San Gallicano Dermatological Institute
Roma, Italy
Sponsors and Collaborators
Laboratoires Genévrier
Investigators
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Principal Investigator: Nanja Van Geel, Pr Gent hospital
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Responsible Party: Laboratoires Genévrier
ClinicalTrials.gov Identifier: NCT02156427    
Other Study ID Numbers: 13INT/VIT01
First Posted: June 5, 2014    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Piebaldism
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Albinism
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Skin Diseases, Genetic
Metabolic Diseases