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

NCT03423004 | Completed

• 1 other identifier: CHRO-2017-12
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

psoriasis; IL-22; miR-21

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation between Psoriasis Area Severity Index and miR-21 expression

  Day 0

Study Arms (2)

Patient with lesional skin

EXPERIMENTAL

the sample will be taken by superficial cutaneous biopsy in psoriasic patients

Procedure: Biopsy

Patients with healthy skin

NO INTERVENTION

the skin will be recovered during a surgical procedure (surgical waste) for patients who will not be opposed

Interventions

Biopsy PROCEDURE

the sample will be taken by superficial cutaneous biopsy in psoriasic patients

Patient with lesional skin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

CHR d'Orleans

Orléans, 45067, France

Location

Related Publications (5)

• 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.

  PMID: 19763149 BACKGROUND

• 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.

  PMID: 15888138 BACKGROUND

• 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.

  PMID: 27999243 BACKGROUND

• 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.

  PMID: 28604127 BACKGROUND

• 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.

  PMID: 19578369 BACKGROUND

MeSH Terms

Conditions

Psoriasis

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ali ARAR, Dr

  CHR d'Orléans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 6, 2018
• Study Start: January 11, 2019
• Primary Completion: July 11, 2019
• Study Completion: July 11, 2019
• Last Updated: December 4, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)