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

Primary Purpose

Psoriasis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biopsy
Sponsored by
Centre Hospitalier Régional d'Orléans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Psoriasis focused on measuring psoriasis, IL-22, miR-21

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHR d'Orleans

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patient with lesional skin

Patients with healthy skin

Arm Description

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

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

Outcomes

Primary Outcome Measures

Increase Ratio
Increase ratio between relative expression of different genes (miR-21 and InterLeukin-22) of psoriatic lesional skin and non-psoriatic skin

Secondary Outcome Measures

Correlation between Psoriasis Area Severity Index and miR-21 expression

Full Information

First Posted
January 31, 2018
Last Updated
December 3, 2019
Sponsor
Centre Hospitalier Régional d'Orléans
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1. Study Identification

Unique Protocol Identification Number
NCT03423004
Brief Title
Study of Molecular Markers in Cutaneous Inflammation Between Psoriatic Lesional Skin and Healthy Non-lesional Skin
Acronym
EMIP
Official Title
Comparative Study of Molecular Markers in Cutaneous Inflammation Between Psoriatic Lesional Skin and Healthy Non-lesional Skin
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 11, 2019 (Actual)
Primary Completion Date
July 11, 2019 (Actual)
Study Completion Date
July 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
psoriasis, IL-22, miR-21

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient with lesional skin
Arm Type
Experimental
Arm Description
the sample will be taken by superficial cutaneous biopsy in psoriasic patients
Arm Title
Patients with healthy skin
Arm Type
No Intervention
Arm Description
the skin will be recovered during a surgical procedure (surgical waste) for patients who will not be opposed
Intervention Type
Procedure
Intervention Name(s)
Biopsy
Intervention Description
the sample will be taken by superficial cutaneous biopsy in psoriasic patients
Primary Outcome Measure Information:
Title
Increase Ratio
Description
Increase ratio between relative expression of different genes (miR-21 and InterLeukin-22) of psoriatic lesional skin and non-psoriatic skin
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Correlation between Psoriasis Area Severity Index and miR-21 expression
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali ARAR, Dr
Organizational Affiliation
CHR d'Orléans
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR d'Orleans
City
Orléans
ZIP/Postal Code
45067
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19763149
Citation
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.
Results Reference
background
PubMed Identifier
15888138
Citation
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.
Results Reference
background
PubMed Identifier
27999243
Citation
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.
Results Reference
background
PubMed Identifier
28604127
Citation
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.
Results Reference
background
PubMed Identifier
19578369
Citation
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.
Results Reference
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Study of Molecular Markers in Cutaneous Inflammation Between Psoriatic Lesional Skin and Healthy Non-lesional Skin

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