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

Primary Purpose

Vitiligo

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
autologous (cellular therapy)
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • service de Dermatologie - Hôpital l'Archet

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

traitement A

traitement B

Arm Description

Lesion 1= graft and lesion 2 = UltraViolet B

Lesion 1 = UltraViolet B and lesion 2 = graft

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Repigmentation> 70% of vitiligo lesion at 6 months
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.
Patient satisfaction
Patient satisfaction and tolerance will be studied using visual analogue scales graded from 0 to 10.

Full Information

First Posted
January 2, 2012
Last Updated
January 31, 2014
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT01511965
Brief Title
Study of Applications of Autologous Epidermal Cells in Liquid Phase in the Treatment of Vitiligo
Acronym
Viticell
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
traitement A
Arm Type
Other
Arm Description
Lesion 1= graft and lesion 2 = UltraViolet B
Arm Title
traitement B
Arm Type
Other
Arm Description
Lesion 1 = UltraViolet B and lesion 2 = graft
Intervention Type
Other
Intervention Name(s)
autologous (cellular therapy)
Intervention Description
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 Outcome Measure Information:
Title
Rate of repigmentation of vitiligo lesion to 12 months
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Repigmentation> 70% of vitiligo lesion at 6 months
Time Frame
6 months
Title
Side effects
Description
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.
Time Frame
12 months
Title
Patient satisfaction
Description
Patient satisfaction and tolerance will be studied using visual analogue scales graded from 0 to 10.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Bahadoran, PH
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
service de Dermatologie - Hôpital l'Archet
City
Nice
ZIP/Postal Code
06200
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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