Clinical trial NCT06068218: Translational Assessment of Vitiligo According to Body Locations
Official title: Translational Assessment of Vitiligo According to Body Locations Translational Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Vitiligo
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


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

Primary outcomes:
measure: skin samples
timeFrame: at inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice - Hôpital de l'Archet
state: Alpes-maritimes
Study officials:
affiliation: CHU de Nice, Service de Dermatologie
name: Passeron Thierry, PhD
role: PRINCIPAL_INVESTIGATOR
References: