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

NCT ID: NCT01511965

Last Updated: 2014-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-11-30

Brief 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

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.

Conditions

Vitiligo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

traitement A

Lesion 1= graft and lesion 2 = UltraViolet B

Group Type: OTHER

autologous (cellular therapy)

Intervention Type: OTHER

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.

traitement B

Lesion 1 = UltraViolet B and lesion 2 = graft

Group Type: OTHER

autologous (cellular therapy)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Bahadoran, PH

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

service de Dermatologie - Hôpital l'Archet

Nice, , France

Countries

France

Other Identifiers

06-API-01

Identifier Type: -

Identifier Source: org_study_id