Study of Applications of Autologous Epidermal Cells in Liquid Phase in the Treatment of Vitiligo — Viticell  

Vitiligo Clinical Trial

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

MAIN CRITERIA

• 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.

SECONDARY CRITERIA

• 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitiligo

• NCT number: NCT01511965
• Study type: Interventional
• Source: Centre Hospitalier Universitaire de Nice
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 2011
• Completion date: November 2012