Status:
COMPLETED
Study of Applications of Autologous Epidermal Cells in Liquid Phase in the Treatment of Vitiligo
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Vitiligo
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01511965
Start Date
May 1 2011
End Date
November 1 2012
Last Update
February 3 2014
Active Locations (1)
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1
service de Dermatologie - Hôpital l'Archet
Nice, France, 06200