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

• ClinicalTrials.gov Identifier: NCT03423004
• Recruitment Status: Completed
• First Posted: February 6, 2018
• Last Update Posted: December 4, 2019
• Sponsor: Centre Hospitalier Régional d'Orléans
• Information provided by (Responsible Party): Centre Hospitalier Régional d'Orléans

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Psoriasis	Procedure: Biopsy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 9 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Comparative Study of Molecular Markers in Cutaneous Inflammation Between Psoriatic Lesional Skin and Healthy Non-lesional Skin
• Actual Study Start Date: January 11, 2019
• Actual Primary Completion Date: July 11, 2019
• Actual Study Completion Date: July 11, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Increase Ratio [ Time Frame: Day 0 ]
   Increase ratio between relative expression of different genes (miR-21 and InterLeukin-22) of psoriatic lesional skin and non-psoriatic skin

Secondary Outcome Measures :

1. Correlation between Psoriasis Area Severity Index and miR-21 expression [ Time Frame: Day 0 ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

France

CHR d'Orleans

Orléans, France, 45067

Sponsors and Collaborators

Centre Hospitalier Régional d'Orléans

Investigators

• Principal Investigator: Ali ARAR, Dr; CHR d'Orléans

More Information

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. Review.

Finlay AY. Current severe psoriasis and the rule of tens. Br J Dermatol. 2005 May;152(5):861-7. Review.

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. doi: IJIv13i4A8.

Carrascosa JM, Toro Montecinos M, Ballescá F, Teniente Serra A, Martínez Cáceres E, Ferrándiz 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.

• Responsible Party: Centre Hospitalier Régional d'Orléans
• ClinicalTrials.gov Identifier: NCT03423004
• Other Study ID Numbers: CHRO-2017-12
• First Posted: February 6, 2018
• Last Update Posted: December 4, 2019
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Régional d'Orléans:

psoriasis; IL-22; miR-21

Additional relevant MeSH terms:

Psoriasis; Inflammation; Pathologic Processes; Skin Diseases, Papulosquamous; Skin Diseases