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Completed

NCT Number: NCT03423004

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHR d'Orleans

Orléans, 45067, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biopsy

Procedure

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

Primary outcomes

  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 outcomes

  1. Correlation between Psoriasis Area Severity Index and miR-21 expression

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

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

Acronym: EMIP

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 6, 2018
Registry last updated
Dec 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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