A Multicenter Trial of Non-cultured Epidermal Cellular Grafting Versus Hyaluronic Acid for Repigmenting Stable Leukoderma (Vitiligo and Piebaldism)
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|ClinicalTrials.gov Identifier: NCT02156427|
Recruitment Status : Unknown
Verified July 2015 by Laboratoires Genévrier.
Recruitment status was: Recruiting
First Posted : June 5, 2014
Last Update Posted : July 9, 2015
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)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||September 2016|
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.
Sham Comparator: PLACEBO
In this arm, lesions will be treated by a suspension of hyaluronic acid without epidermal cells.
- Successful repigmentation: more than or equal to 50% repigmentation of the treated area [ Time Frame: up to month 12 ]
- Repigmentation rate ≥ 50% of the treated area [ Time Frame: month 12 ]
- Number of adverse events in each group [ Time Frame: Day 0/Day 6-7/Month 3/6/9/12 ]
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
|Contact: Anissa Taverne, Dr.||+ 33 firstname.lastname@example.org|
|Department of Dermatology - Ghent University Hospital||Recruiting|
|Contact: Nanja van Geel, Prof. Dr. + 32-93322298 Nanja.vangeel@UGent.be|
|Principal Investigator: Nanja Van Geel, Prof. Dr.|
|University Hospital Center of Bordeaux||Recruiting|
|Contact: Alain Taieb, Pr +33 556794975 email@example.com|
|Principal Investigator: Alain Taieb, Pr|
|Sub-Investigator: Antoine Bertolotti, Dr|
|Sub-Investigator: Julien Senechal, Dr|
|CHU Le Mans||Recruiting|
|Le Mans, France|
|Contact: Hervé Maillard, Dr +33 243434358|
|Dr Michel PASCAL||Recruiting|
|Contact: Michel Pascal, Dr +33 143679259 firstname.lastname@example.org|
|San Gallicano Dermatological Institute||Recruiting|
|Contact: Giovanni Leone, Dr. + 39-0652665982 email@example.com|
|Principal Investigator: Giovanni Leone, Dr.|