Study of Molecular Markers in Cutaneous Inflammation Between Psoriatic Lesional Skin and Healthy Non-lesional Skin (EMIP)

Comparative Study of Molecular Markers in Cutaneous Inflammation Between Psoriatic Lesional Skin and Healthy Non-lesional Skin

The project topic consists on re-conciliating the fine tuners of the gene expression "microRNAs" and the immunopathogenic occasions responsible for skin disorders in context of skin infection and inflammation such as psoriasis. The skin is a network of effector cells and molecular mediators that constitute a highly sophisticated "Skin Immune System (SIS) described by Jan D Bos in 1986. The cutaneous homeostasis maintenance is dependent on the cross talk between several immune sentinels present in the different compartments of the skin as well as the interplay between innate and adaptive immune responses. The whole is under the control of gene regulation. However, cutaneous homeostasis disruption occurs when the SIS safe framework erroneously sends aggravation signals due to gene regulation disbalance via inflammatory cellular and molecular mediators into the site of infection causing chronic inflammation characterized by thick red irritated skin lesions. The latter was showed to have a characteristic microRNA (regulators of gene expression) signature.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Procedure: Biopsy

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Orléans, France, 45067
    • CHR d'Orléans

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men or women between 18 and 75
• Clinical diagnosis of chronic active psoriasis in non-pustular plaque
• Treated locally with topical corticosteroids

Exclusion Criteria:

• Patient who did not give express consent to participate
• No affiliation to a social security scheme
• Patient treated systemically
• Thrombocytopenic patient
• Patient known to be HIV-positive
• Septic patient
• Patient with only facial lesions
• Patient with psoriasis with joint involvement
• Patient participating in another study
• Patient protected under the law (under guardianship or trusteeship)
• Pregnant or lactating woman

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient with lesional skin; the sample will be taken by superficial cutaneous biopsy in psoriasic patients	Procedure: Biopsy; the sample will be taken by superficial cutaneous biopsy in psoriasic patients
No Intervention: Patients with healthy skin; the skin will be recovered during a surgical procedure (surgical waste) for patients who will not be opposed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase Ratio	Increase ratio between relative expression of different genes (miR-21 and InterLeukin-22) of psoriatic lesional skin and non-psoriatic skin	Day 0

Secondary Outcome Measures

Outcome Measure	Time Frame
Correlation between Psoriasis Area Severity Index and miR-21 expression	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional d'Orléans
• Investigators: Principal Investigator: Ali ARAR, Dr, CHR d'Orléans

Publications and helpful links

General Publications

• Nestle FO, Di Meglio P, Qin JZ, Nickoloff BJ. Skin immune sentinels in health and disease. Nat Rev Immunol. 2009 Oct;9(10):679-91. doi: 10.1038/nri2622. Epub 2009 Sep 18.
• Finlay AY. Current severe psoriasis and the rule of tens. Br J Dermatol. 2005 May;152(5):861-7. doi: 10.1111/j.1365-2133.2005.06502.x.
• Sobhan MR, Farshchian M, Hoseinzadeh A, Ghasemibasir HR, Solgi G. Serum Levels of IL-10 and IL-22 Cytokines in Patients with Psoriasis. Iran J Immunol. 2016 Dec;13(4):317-323.
• Carrascosa JM, Toro Montecinos M, Ballesca F, Teniente Serra A, Martinez Caceres E, Ferrandiz C. Correlation between trough serum levels of adalimumab and absolute PASI score in a series of patients with psoriasis. J Dermatolog Treat. 2018 Mar;29(2):140-144. doi: 10.1080/09546634.2017.1341619. Epub 2017 Jul 6.
• Duhen T, Geiger R, Jarrossay D, Lanzavecchia A, Sallusto F. Production of interleukin 22 but not interleukin 17 by a subset of human skin-homing memory T cells. Nat Immunol. 2009 Aug;10(8):857-63. doi: 10.1038/ni.1767. Epub 2009 Jul 5.

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2019
• Primary Completion (Actual): July 11, 2019
• Study Completion (Actual): July 11, 2019

Study Registration Dates

• First Submitted: January 31, 2018
• First Submitted That Met QC Criteria: January 31, 2018
• First Posted (Actual): February 6, 2018

Study Record Updates

• Last Update Posted (Actual): December 4, 2019
• Last Update Submitted That Met QC Criteria: December 3, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: psoriasis; IL-22; miR-21
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Diseases, Papulosquamous; Inflammation; Psoriasis
• Other Study ID Numbers: CHRO-2017-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No