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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||double-blind, prospective, multicenter, randomised, controlled trial patient is his own control|
|Masking:||Double (Participant, Investigator)|
|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|
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.
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.
hyaluronic acid alone
- Rate of successful repigmentation [ Time Frame: at month 6 ]succesful repigementation define as more than or equal to 50% repigmentation of the treated area
- Rate of successful repigmentation [ Time Frame: at month 12 ]succesful repigementation define as more than or equal to 50% repigmentation of the treated area
- Number of adverse events in each group [ Time Frame: Day 0/Day 6-7/Month 3/6/9/12 ]
- Mean reduction of treated area [ Time Frame: Month 3/6/9/12 ]calculated in pourcentage from baseline
- Variation of area size [ Time Frame: Day 0/Month 3/6/9/12 ]Size in cm² measured at each visit
- 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).
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
|Department of Dermatology - Ghent University Hospital|
|University Hospital Center of Bordeaux|
|CHU Le Mans|
|Le Mans, France|
|Dr Michel PASCAL|
|San Gallicano Dermatological Institute|
|Principal Investigator:||Nanja Van Geel, Pr||Gent hospital|