Clinical Trials Directory

Trials / Completed

CompletedNCT04193670

Sensory Nociceptive Nerve Fibers, Key Regulator of Immune Response Type 2 in Atopic Dermatitis

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
18 (actual)
Sponsor
University Hospital, Toulouse · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

The skin is innervated by a network of nociceptive sensory neurons (nociceptors) whose primary function is the transmission of pain and pruritus signals to the central nervous system. Their role in atopic dermatitis (AD), characterized by an exacerbated type 2 immune response, is only partially understood. Nevertheless, large amounts of neuropeptides, including substance P (SP), are found in the serum of patients, their level being correlated with the clinical severity of AD. Mast cells (MC) are part of the cells of the immune system residing in the skin. MCs have neuro-receptors of the Mas-related G protein-coupled receptors family (MRGPR) and in particular MRGPRX2 (the receptor for cationic molecules \[including SP\] for MCs) through which they could communicate in a privileged way. with the nociceptors. Preliminary data obtained in mice show that its mouse orthologue "MrgprB2" is absolutely necessary for the development of type 2 immunity and the pathological characteristics of a preclinical "DA-like" model (manuscript in preparation). The investigators therefore hypothesize that the activation of MCs expressing MRGPRX2 by nociceptors producing SP plays a key role in the development of type 2 inflammation in AD in humans.

Conditions

Interventions

TypeNameDescription
OTHERClinical examinationThis is a classic dermatological clinical examination during a classic consultation
PROCEDUREBiopsies2 skin biopsies on a lesion area selected according to the inclusion criteria (2 punchs of 4 mm) for each experimental group. The first half of whole cutaneous biopsies (n = 25) will be studied using biphotonic microscopy. This will be performed on whole biopsies in 3-D according to the protocol developed in the laboratory. The second half of whole skin biopsies (n = 25) will be studied using the technique of single-cell RNA seq. The skin controls skin-free subjects will be obtained from skin reduction surgery (abdominoplasty) to subjects who have agreed to the use of their skin sample.
OTHERBlood testA blood test on a tube (2 tubes of 10 mL).An assay of specific IgE and the serum level of IL-4, IL-13 and IL-5 will be carried out by ELISA (Enzyme Linked ImmunoSorbent Assay) from the blood samples.The blood samples will be obtained through the French blood establishment from different donors who have given their consent.

Timeline

Start date
2019-05-07
Primary completion
2022-02-03
Completion
2022-12-31
First posted
2019-12-10
Last updated
2023-07-24

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04193670. Inclusion in this directory is not an endorsement.