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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01511965
First received: January 2, 2012
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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

Condition Intervention Phase
Vitiligo
Other: autologous (cellular therapy)
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • Rate of repigmentation of vitiligo lesion to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Repigmentation> 70% of vitiligo lesion at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Side effects [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Patient satisfaction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Patient satisfaction and tolerance will be studied using visual analogue scales graded from 0 to 10.


Enrollment: 23
Study Start Date: May 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511965

Locations
France
service de Dermatologie - Hôpital l'Archet
Nice, France, 06200
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Philippe Bahadoran, PH Chu de Nice
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01511965     History of Changes
Other Study ID Numbers: 06-API-01
Study First Received: January 2, 2012
Last Updated: January 31, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on October 01, 2014