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

Vitiligo Clinical Trial

— Viticell  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01511965
• Other study ID #: 06-API-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 2, 2012
• Last updated: January 31, 2014
• Start date: May 2011
• Est. completion date: November 2012

Study information

• Verified date: January 2014
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Vitiligo

Intervention

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.

Locations

Country	Name	City	State
France	service de Dermatologie - Hôpital l'Archet	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Repigmentation> 70% of vitiligo lesion at 6 months		6 months	No
Secondary	Side effects	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.	12 months	No
Secondary	Patient satisfaction	Patient satisfaction and tolerance will be studied using visual analogue scales graded from 0 to 10.	12 months	No