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

NCT01511965 | Completed Phase 1

• 1 other identifier: 06-API-01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Repigmentation> 70% of vitiligo lesion at 6 months

  6 months

• Side effects

  12 months

• Patient satisfaction

  12 months

Study Arms (2)

traitement A

OTHER

Lesion 1= graft and lesion 2 = UltraViolet B

Other: autologous (cellular therapy)

traitement B

OTHER

Lesion 1 = UltraViolet B and lesion 2 = graft

Other: autologous (cellular therapy)

Interventions

autologous (cellular therapy) 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 A; traitement B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

service de Dermatologie - Hôpital l'Archet

Nice, 06200, France

Location

MeSH Terms

Conditions

Vitiligo

Interventions

Cell- and Tissue-Based Therapy

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Philippe Bahadoran, PH

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2012
• First Posted: January 19, 2012
• Study Start: May 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: February 3, 2014

Record last verified: 2014-01

Locations

FR (1)