Analysis of Inflammation in the Vitiligo and Other Inflammatory Skin Diseases: Psoriasis, Atopic Dermatitis and Alopecia Areata

Psoriasis Clinical Trial

— INFLAMMAVit  

Official title:

Analysis of Inflammation in the Vitiligo and Other Inflammatory Skin Diseases: Psoriasis, Atopic Dermatitis and Alopecia Areata

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03976622
• Other study ID #: CHUBX 2017/55
• Status: Not yet recruiting
• Start date: June 3, 2019
• Est. completion date: June 3, 2023

Study information

• Verified date: May 2019
• Source: University Hospital, Bordeaux
• Contact: Julien SENESCHAL, MD,PhD
• Phone: +335 56 79 49 63
• Email: julien.seneschal[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

It is a study of translational research with mechanistically objectives and including biological samples of patients with chronic inflammatory disorders

Description:

This study was a single-center prospective study to collect blood and skin tissue at the time of consultation with a patient with non-segmental vitiligo, psoriasis, atopic dermatitis or alopecia areata, in order to better understand and compare blood and skin immune response in chronic inflammatory skin disorders: psoriasis, alopecia areata, atopic dermatitis and vitiligo.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: June 3, 2023
• Est. primary completion date: June 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients aged 18 to 75 years;

• Patients with non-segmental vitiligo;

• Patients with plaque psoriasis;

• Patients with atopic dermatitis;

• Patients with alopecia areata sclerosis;

• written consent, free, informed and signed by the patient and the investigator (before any examination required by the study);

• Subject affiliated or beneficiary of a social security system.

Exclusion Criteria:

• Patients with segmental vitiligo

• Patients under local treatment (topical corticosteroid-Calcineurin inhibitor) for less than two weeks.

• Patients on therapy, systemic treatments: acitretin, methotrexate, cyclosporine, Apremilast, infliximab, adalimumab, etanercept, ustekinumab, secukinumab, ixekizumab, dupilumab) for less than 4 weeks.

• Pregnant or breastfeeding women

• Patient (e) under guardianship

• Patient (e) Non-affiliated (e) a social protection

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Inflammation
• Psoriasis
• Skin Diseases
• Vitiligo

Intervention

Biological:
• Blood samples
Blood samples: serum and PBMC
• Skin biopsies
These superficial skin biopsies under local anesthesia in skin areas with the exception of the face and folds.

Locations

Country	Name	City	State
France	Service de Dermatologie - Hôpital Saint-André	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of the phenotype and function of blood and skin T-cell in chronic inflammatory skin disorders: psoriasis, vitiligo, atopic dermatitis, alopecia areata	Description of the phenotypic analysis of cutaneous T-cell and blood of vitiligo patients evaluated by flow cytometry	Day 1