Clinical Trial: A Multicenter Trial of Non-cultured Epidermal Cellular Grafting Versus Hyaluronic Acid for Repigmenting Stable Leukoderma (Vitiligo and Piebaldism)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title:
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.
Detailed Summary:
Sponsor: Laboratoires Genévrier
Current Primary Outcome: Successful repigmentation: more than or equal to 50% repigmentation of the treated area [ Time Frame: up to month 12 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Repigmentation rate ≥ 50% of the treated area [ Time Frame: month 12 ]
Original Secondary Outcome: Same as current
Information By: Laboratoires Genévrier
Dates:
Date Received: May 30, 2014
Date Started: May 2014
Date Completion:
Last Updated: July 8, 2015
Last Verified: July 2015