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Completed

NCT Number: NCT02156427

Evaluation of Non-cultured Epidermal Cellular Grafting vs Hyaluronic Acid for Repigmenting 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.

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Key information

Conditions

Vitiligo Albinism Amino Acid Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases, Hereditary Genetic Diseases, Inborn Hypopigmentation Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases Piebaldism Pigmentation Disorders Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Dermatology - Ghent University Hospital, Ghent, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VITICELL

Device

graft of autologus cells (kaeratonicytes and melanocytes) obtained after trypsinization of thin skin biopsy resuspended into hyaluronic acid

PLACEBO

Device

hyaluronic acid alone

Primary outcomes

  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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Laboratoires Genévrier

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 5, 2014
Registry last updated
Oct 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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