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Completed

NCT Number: NCT01511965

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

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

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Key information

Conditions

Vitiligo Hypopigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

service de Dermatologie - Hôpital l'Archet

Nice, 06200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Rate of repigmentation of vitiligo lesion to 12 months

    Time frame: 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.

Secondary outcomes

  1. Repigmentation> 70% of vitiligo lesion at 6 months

    Time frame: 6 months

  2. Side effects

    Time frame: 12 months

    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.

  3. Patient satisfaction

    Time frame: 12 months

    Patient satisfaction and tolerance will be studied using visual analogue scales graded from 0 to 10.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: Viticell

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 19, 2012
Registry last updated
Feb 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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