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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03423004
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Centre Hospitalier Régional d'Orléans
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ali ARAR, Dr
Principal Investigator Affiliation CHR d'Orléans
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Arms & Interventions

Arms

Experimental: Patient with lesional skin

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

Interventions

Procedure: - Biopsy

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

Contact a Trial Team

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International Sites

CHR d'Orleans, Orléans, France

Status

Recruiting

Address

CHR d'Orleans

Orléans, , 45067

Site Contact

Ali ARAR, Dr

ali.arar@chr-orleans.fr

0033238514786

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