Study of Applications of Autologous Epidermal Cells in Liquid Phase in the Treatment of Vitiligo (Viticell)
Vitiligo is a depigmenting skin disease common. Vitiligo is caused by the disappearance of melanocytes in the epidermis. Vitiligo is the cause of disfigurement, psychological and social, that sounds a lot about the quality of life. Currently the standard treatment for vitiligo is ultraviolet ray (UV), but it only allows a 50% repigmentation of lesions in half of patients. The applications of autologous epidermal cells in the liquid phase is a promising new therapeutic approach of vitiligo.
The main goal of this study is to compare prospectively the repigmentation of vitiligo lesions induced by application of autologous epidermal cells in liquid phase associated with light therapy and light therapy alone.
Study's secondary goals: compare the applications of epidermal cells to phototherapy alone and phototherapy, in respect of:
- Obtain a repigmentation> 70% (threshold considered aesthetically relevant)
- The occurrence of adverse events
- Patient satisfaction regarding the efficacy and safety of treatment
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
- Rate of repigmentation of vitiligo lesion to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]The lesions defined by the investigator to Month 0, Month 3, Month 6 and Month 12 will be analyzed by an image analysis system managed by a PC computer. Digital photos will be taken in order to illustrate the quantitative results above.
- Repigmentation> 70% of vitiligo lesion at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Side effects [ Time Frame: 12 months ] [ Designated as safety issue: No ]the frequency, severity and time of occurrence of side effects will be reported for each treatment. Side effects are classified into grades according to WHO criteria.
- Patient satisfaction [ Time Frame: 12 months ] [ Designated as safety issue: No ]Patient satisfaction and tolerance will be studied using visual analogue scales graded from 0 to 10.
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||November 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Lesion 1= graft and lesion 2 = UltraViolet B
Other: autologous (cellular therapy)
The skin sample, the preparation and implementation of the epidermal cells, are conducted on one day. A review of selected lesions is performed and a photograph. Second, are performed successively in a single day the collection of thin skin, preparing the cell suspension, a desepidermisation laser Erbium: YAG lesions of vitiligo to be grafted, and applicated.
Lesion 1 = UltraViolet B and lesion 2 = graft
Other: autologous (cellular therapy)
- Rates of repigmentation of the vitiligo lesions to 12 months
- The lesions of the layers defined by the investigator to Month 0, Month 3, Month 6 and Month 12 will be analyzed by an image analysis system managed by a computer.
- Digital photos is taken in order to illustrate the quantitative results above.
- Repigmentation> 70% of the vitiligo lesions at 12 months
- Rates of repigmentation of the vitiligo lesions at 12 months
- Side effects: the frequency, severity and time of occurrence will be reported for each treatment. Side effects are classified into grades according to World Health Organization (WHO) criteria.
- Patient satisfaction of the effectiveness and tolerance will be studied using visual analogue scales graded from 0 to 10.
|Contact: Philippe BAHADORAN, PHemail@example.com|
|service de Dermatologie - Hôpital l'Archet||Recruiting|
|Nice, France, 06200|
|Contact: Philippe Bahadoran, PH firstname.lastname@example.org|
|Contact: Cassandre LANDES, ingenieur 04 92 03 45 88 email@example.com|
|Principal Investigator: Philippe BAHADORAN, PH|
|Principal Investigator:||Philippe Bahadoran, PH||Chu de Nice|