Atopic DermatitisIMMCEPTIONNCT04193670
Sensory Nociceptive Nerve Fibers, Key Regulator of Immune Response Type 2 in Atopic Dermatitis
A study testing Clinical examination, Biopsies and Blood test in people with Atopic Dermatitis, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Clinical examination, Biopsies and Blood test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 7 May 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Criteria for the study population:
- Subject affiliated with a social security scheme or beneficiary of such a scheme;
- subject who has given written consent to participate in the study;
- Subject accepting a blood test to check for the absence of infectious diseases (HIV serologies, Hepatitis B, Hepatitis C) in the event of a blood exposure accident;
- Subject who did not apply emollient care products to the areas to be biopsied within 24 hours prior to the inclusion visit.
- Subject accepting biopsies
Show all 13Show fewer
- Criteria related to the pathology studied:
- Subject with atopic dermatitis according to UK Working Party criteria or Williams criteria with an IGA score ≥ 3 (group 1)
- Subject with atopic dermatitis according to UK Working party criteria or Williams criteria in the form of an atopic prurigo diagnosed by the dermatologist (group 2)
- Criteria relating to control subjects: Subjects who had abdominoplasty and agreed to use their skin sample as part of Genoskin (Ministerial Approval # AC-2017-2897) (Group 3).
- Criteria for treatment:
- Systemic treatments for AD (including phototherapy) or biotherapies interrupted at least 4 weeks before the inclusion visit;
- Topical treatments: topical corticosteroids and tacrolimus stopped on the biopsied area at least 7 days before the inclusion visit.
Who cannot join
- Criteria for the study population:
- Solar exposure of biopsied areas planned during the study;
- Subject having had exposure to solar radiation or artificial UV within 2 weeks before inclusion in biopsied areas.
- Criteria related to the pathology studied:
- Chronic inflammatory dermatosis other than classical AD or atopic prurigo at sites to be harvested;
- Subject with a known history of allergy or intolerance to local anesthetics, local antiseptics to latex or plaster;
Show all 25Show fewer
- Subject already having abnormalities of healing
- Subject with a recognized addiction to alcoholism or drug addiction;
- Subject having an inherited or acquired disease of hemostasis;
- Subject having a severe or acute chronic condition deemed by the investigator to be inconsistent with the trial;
- Subject with immunodeficiency clinically incompatible with the study.
- Criteria for treatment:
- Any topical or systemic treatment of AD (including phototherapy) in progress
- Treatment likely to act on the haemostasis (example: anticoagulants, antiaggregating platelet ...) in the 4 weeks preceding the inclusion and during the study;
- General corticosteroids in the 4 weeks prior to the inclusion visit
- ongoing systemic treatment that may interfere with the healing process;
- Subject having undergone a physical treatment (radiotherapy, ...) on the area to be biopsied, during the last 6 months.
- History of treatment or concomitant treatment that may interfere with the completion of the study according to the opinion of the investigator.
- Criteria for regulation:
- Subject unable to comply with protocol requirements;
- Subject in linguistic or psychic incapacity to sign informed consent;
- Subject being in a period of exclusion during which he can not participate in any other biomedical research;
- Subject participating in another biomedical research;
- Subject deprived of liberty by judicial or administrative decision, under guardianship, curatorship or safeguard of justice;
- Person with severely impaired physical and / or psychological health who, according to the investigator, may affect participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Atopic Dermatitis
- Being tested
- Clinical examination, Biopsies, Blood test
- Keywords
- nociceptors- immune response, atopic prurigo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examinationOther
This is a classic dermatological clinical examination during a classic consultation
BiopsiesProcedure or surgery
2 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.
Blood testOther
A 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.
| Study group | Role | What they receive |
|---|---|---|
| Atopic dermatitis classical form | Experimental | 15 patients Receives: Other: Clinical examination; Procedure: Biopsies; Other: Blood test |
| Atopic dermatitis with atopic prurigo type | Experimental | 10 patients Receives: Other: Clinical examination; Procedure: Biopsies; Other: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of neuronal interactions by two-photon microscopy
quantification by two-photon microscopy of the density of nerve fibers producing SP, the density of MRGPRX2 + MCs, the spatial proximity between nerve fibers and MC and quantification of the degranulated appearance of MC in the lesional skin of patients with DA classical form and DA atopic prurigo type in comparison to the skin of control subjects.
Measured: 13 months
Secondary outcomes (2)
Marker analysis by ELISA assay
Analyze the intensity of type 2 immunity markers (Specific IgE Assay for Dermatophagoids Farinae, IL-4, IL-13 and IL-5) in the blood of patients with classical AD and atopic prurigo type AD.
Measured: 13 months
Cellular analysis
To analyze the diversity of cellular subtypes present in the skin of patients with classical AD and atopic prurigo type DA.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start7 May 2019
- Primary completion3 Feb 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie TAUBER, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193670
- Sponsor's protocol ID
- RC31/19/0118
- Acronym
- IMMCEPTION
- Status last verified
- Jul 2023
- First submitted
- 3 Dec 2019
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Nociceptive Nerve Fibers, Key Regulator of Immune Response Type 2 in Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT04193670
- Acronym / sponsor ID
- IMMCEPTION / RC31/19/0118
- Conditions
- Atopic Dermatitis
- Keywords
- nociceptors- immune response, atopic prurigo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 7 May 2019 (actual)
- Primary completion
- 3 Feb 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atopic dermatitis classical form | Experimental | Other: Clinical examination, Procedure: Biopsies, Other: Blood test15 patients |
| Atopic dermatitis with atopic prurigo type | Experimental | Other: Clinical examination, Procedure: Biopsies, Other: Blood test10 patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject affiliated with a social security scheme or beneficiary of such a scheme;
- subject who has given written consent to participate in the study;
- Subject accepting a blood test to check for the absence of infectious diseases (HIV serologies, Hepatitis B, Hepatitis C) in the event of a blood exposure accident;
- Subject who did not apply emollient care products to the areas to be biopsied within 24 hours prior to the inclusion visit.
- Subject accepting biopsies
Key exclusion criteria (25 listed)
- Criteria for the study population:
- Chronic inflammatory dermatosis other than classical AD or atopic prurigo at sites to be harvested;
- Subject with a known history of allergy or intolerance to local anesthetics, local antiseptics to latex or plaster;
- Subject already having abnormalities of healing
- Subject with a recognized addiction to alcoholism or drug addiction;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical examinationThis is a classic dermatological clinical examination during a classic consultation | Other | Atopic dermatitis classical form, Atopic dermatitis with atopic prurigo type |
| Biopsies2 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. | Procedure or surgery | Atopic dermatitis classical form, Atopic dermatitis with atopic prurigo type |
| Blood 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. | Other | Atopic dermatitis classical form, Atopic dermatitis with atopic prurigo type |
Primary outcome
Characterization of neuronal interactions by two-photon microscopy
Time frame: 13 months
quantification by two-photon microscopy of the density of nerve fibers producing SP, the density of MRGPRX2 + MCs, the spatial proximity between nerve fibers and MC and quantification of the degranulated appearance of MC in the lesional skin of patients with DA classical form and DA atopic prurigo type in comparison to the skin of control subjects.
2 secondary outcomes
Marker analysis by ELISA assay
Time frame: 13 months
Cellular analysis
Time frame: 13 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie TAUBER principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical examination, Biopsies and Blood test in people with Atopic Dermatitis, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of neuronal interactions by two-photon microscopy (time frame: 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.