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

NCT02156427 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2019-10-14

No results posted yet for this study

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.

Conditions

  • Vitiligo
  • Piebaldism

Interventions

DEVICE

VITICELL

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

DEVICE

PLACEBO

hyaluronic acid alone

Sponsors & Collaborators

  • Laboratoires Genévrier

    lead INDUSTRY

Principal Investigators

  • Nanja Van Geel, Pr · Gent hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-29
Primary Completion
2018-04-10
Completion
2018-04-10

Countries

  • Belgium
  • France
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02156427 on ClinicalTrials.gov