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

Psoriasis Clinical Trial

— EMIP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03423004
• Other study ID #: CHRO-2017-12
• Status: Completed
• Phase: N/A
• Start date: January 11, 2019
• Est. completion date: July 11, 2019

Study information

• Verified date: December 2019
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: July 11, 2019
• Est. primary completion date: July 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Psoriasis

Intervention

Procedure:
• Biopsy
the sample will be taken by superficial cutaneous biopsy in psoriasic patients

Locations

Country	Name	City	State
France	CHR d'Orleans	Orléans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View 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. — View Citation

Finlay AY. Current severe psoriasis and the rule of tens. Br J Dermatol. 2005 May;152(5):861-7. Review. — View 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. Review. — View 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. doi: IJIv13i4A8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation between Psoriasis Area Severity Index and miR-21 expression		Day 0