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 Overview

• Status: Completed
• Conditions: Vitiligo
• Intervention / Treatment: Other: autologous (cellular therapy)

Detailed 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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• France
  • Nice, France, 06200
    • service de Dermatologie - Hôpital l'Archet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Elderly patients at least 18 years
• Subjects with a stable vitiligo (no new injury or lack of expansion of existing lesions in the last 12 months), with at least two vitiligo lesions of at least 10 cm2 located in the same anatomical location, and requiring treatment with UVB phototherapy.
• Topic with vitiligo
• Subjects who agreed to have a blood research with Human immunodeficiency virus (HIV), Human T-lymphotropic virus - 1 (HTLV-1), hepatitis B, hepatitis C, and human Chorionic Gonadotropinfor (hCG) women.
• For women of childbearing age, the use of effective contraception (birth control pills or Intrauterine Device (IUD)) for the duration of the study
• Topics able to participate and to respect it.
• Topics affiliated to social security.
• Topics that have signed a written informed consent before the start of the study.

Exclusion Criteria:

• Pregnant or nursing women.
• Subjects with a history of keloid scarring.
• Subjects with a history of melanoma.
• Subjects with a photodermatitis.
• Topics taking photosensitizing treatment.
• Subjects who received treatment for vitiligo in the 4 weeks before enrollment.
• Subjects with HIV testing, hepatitis B or hepatitis C positive.
• Major Topics protected by law

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: traitement A; 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.
Other: traitement B; Lesion 1 = UltraViolet B and lesion 2 = graft	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of repigmentation of vitiligo lesion to 12 months	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repigmentation> 70% of vitiligo lesion at 6 months		6 months
Side effects	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.	12 months
Patient satisfaction	Patient satisfaction and tolerance will be studied using visual analogue scales graded from 0 to 10.	12 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Philippe Bahadoran, PH, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: January 2, 2012
• First Submitted That Met QC Criteria: January 13, 2012
• First Posted (Estimate): January 19, 2012

Study Record Updates

• Last Update Posted (Estimate): February 3, 2014
• Last Update Submitted That Met QC Criteria: January 31, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: 06-API-01