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Translational Assessment of Vitiligo According to Body Locations (Vitiligo BL)

Primary Purpose

Vitiligo

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biopsy for the patient group
biopsy for the volunteer group
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Vitiligo

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Men and women with non-segmental vitiligo for the vitiligo group and men and women without any auto-immune disorder for the control group ≥ 18 and <70 years For women of child-bearing age, a urine pregnancy test (βHCG in urines) will be performed. Affiliation to a social security system Signed informed consent Exclusion Criteria: Pregnant women Segmental or mixed vitiligo Vitiligo with less than 2 years duration Skin auto-immune or inflammatory skin disorders other than vitiligo (ie. active atopic dermatitis, psoriasis, lichen planus…) Exposure to sun (with intent to tan or repigment the skin) or artificial UV (UV cabins, lamps or lasers) during the month before inclusion Concomitant use of topical or systemic immunosuppressive medication or steroids Contra-indication to xylocaine with 2 % adrenalin Pregnant or breast-feeding women Vulnerable people: minors, adult under guardianship or deprived of freedom, adult under curatorship Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation

Sites / Locations

  • CHU de Nice - Hôpital de l'Archet

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patient Group

Volunteer group

Arm Description

Outcomes

Primary Outcome Measures

skin samples
Transcriptomic profiling by sequencing method will be performed on the skin samples

Secondary Outcome Measures

Full Information

First Posted
September 5, 2023
Last Updated
October 3, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT06068218
Brief Title
Translational Assessment of Vitiligo According to Body Locations
Acronym
Vitiligo BL
Official Title
Translational Assessment of Vitiligo According to Body Locations Translational Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2, 2023 (Anticipated)
Primary Completion Date
October 2, 2024 (Anticipated)
Study Completion Date
October 2, 2025 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Vitiligo affects 0.5 to 2% of worldwide population and has a demonstrated impact on the quality of life. Optimal treatment of vitiligo requires to target the auto-immune inflammatory response (to halt the depigmentation process), but also to induce the differentiation of melanocyte stem cells (to induce repigmentation). There is a well demonstrated discrepancy in the repigmentation response between anatomical areas of the body. Face and neck are the best responder with complete or almost complete repigmentation achieved in most cases under treatment. Trunk and limbs could have a complete or almost complete repigmentation in approximately half of the cases. The repigmentation is much more difficult in wrists, elbows, knees, proximal part of the hands. Finally, some areas such as the extremities of hands and feet, palms, soles, are almost impossible to repigment. The investigator hypothesize that there are some factors that are produced in the skin that prevent (or at least decrease) the differentiation but also probably the migration and proliferation of melanocytes. Primary objective To compare the mRNA expression of each types of cells in the skin of vitiligo patients compared to healthy volunteers according to body locations

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
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient Group
Arm Type
Other
Arm Title
Volunteer group
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Biopsy for the patient group
Intervention Description
The investigator will perform a 4mm skin biopsy will be performed on 5 body sites: neck, trunk, elbows, wrist and feet. For vitiligo patients, the biopsies will be taken on a non-depigmented skin.
Intervention Type
Other
Intervention Name(s)
biopsy for the volunteer group
Intervention Description
A publicity in the hospital will announce the study, and will be use to recruit the healthy volunteers. The investigator will perform a 4mm skin biopsy will be performed on 5 body sites: neck, trunk, elbows, wrist and feet.
Primary Outcome Measure Information:
Title
skin samples
Description
Transcriptomic profiling by sequencing method will be performed on the skin samples
Time Frame
at inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men and women with non-segmental vitiligo for the vitiligo group and men and women without any auto-immune disorder for the control group ≥ 18 and <70 years For women of child-bearing age, a urine pregnancy test (βHCG in urines) will be performed. Affiliation to a social security system Signed informed consent Exclusion Criteria: Pregnant women Segmental or mixed vitiligo Vitiligo with less than 2 years duration Skin auto-immune or inflammatory skin disorders other than vitiligo (ie. active atopic dermatitis, psoriasis, lichen planus…) Exposure to sun (with intent to tan or repigment the skin) or artificial UV (UV cabins, lamps or lasers) during the month before inclusion Concomitant use of topical or systemic immunosuppressive medication or steroids Contra-indication to xylocaine with 2 % adrenalin Pregnant or breast-feeding women Vulnerable people: minors, adult under guardianship or deprived of freedom, adult under curatorship Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Passeron Thierry, PhD
Phone
+33492036488
Email
passeron.t@chu-nice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Pradelli emmanuelle
Email
pradelli.e@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Passeron Thierry, PhD
Organizational Affiliation
CHU de Nice, Service de Dermatologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice - Hôpital de l'Archet
City
Nice
State/Province
Alpes-maritimes
ZIP/Postal Code
06200
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PASSERON thierry, PhD
Phone
+33492036488
Email
passeron.t@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Pradelli emmanuelle
Email
pradelli.e@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Passeron Thierry, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Translational Assessment of Vitiligo According to Body Locations

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