EczemaSMECANCT06124781
Molecular Diagnosis of Allergic Contact Dermatitis (SMECA).
A study testing Blood sample, Skin biopsies and ROAT test in people with Eczema and Allergic Contact Eczema Nos, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 5 sites in 2 countries.
Trial summary
Allergic contact dermatitis (ACD) is a common inflammatory skin disease, which represents a major public health issue in industrialized countries. ACD is induced by repeated contact of individuals with environmental chemicals and is characterized by a delayed type IV hypersensitivity response with skin inflammation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eczema, Allergic Contact Eczema Nos
- What is being tested?
- Blood sample, Skin biopsies and ROAT test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 20 Jun 2023to 20 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient, male or female, over 18 years of age.
- Patient with at least one positive/doubtful patch test reaction for nickel, limonene hydroperoxide and/or linalool hydroperoxide
- Patient agreeing to undergo skin biopsies and blood sampling
- Patient agreeing to non-identifying pictures being taken of lesions
- Patient available to carry out skin tests and their interpretation
- Patient affiliated to or benefiting from a social security regime
- Patient having been informed and having signed a written, free and informed consent.
Who cannot join
- Patient with active dermatitis lesions on the forearm
- Patient with a history of allergic reaction to a local anesthetic product
- Patient with wound healing disorders (hypertrophic or keloids scars)
- Patient with hematological disorders
- Patient having topical treatments with corticosteroids or immunomodulators on the forearms during the 21 days prior to the start of the study
- Patient having had excessive exposure to ultraviolet during the 21 days prior to the start of the study.
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- Patient on systemic corticosteroid therapy, immunosuppressants or biological therapy.
- Patient whose follow-up is impossible for reasons psychological or geographical.
- Patient taking part in another clinical study
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- Pregnant, breast-feeding or parturient woman
Trial locations and contacts
5 sites in 2 countries.
Marie Hélène Barba contact
5 sites in 2 countries
France4 sites, 4 recruiting
- Recruiting
CHU de Grenoble
La Tronche, 38700
Pauline Pralong, MD, ppralong@chu-grenoble.fr
- Recruiting
CHU Lyon Sud
Pierre-Bénite, 69495
Florence Hacard, MD, florence.hacard@chu-lyon.fr
- Recruiting
Hopital Privé de la Loire
Saint-Etienne, 42100
Charles DZVIGA, MD, 33 (0)6 86 08 40 52, charles.dzviga@wanadoo.fr
- Recruiting
CHU de Saint Etienne
Saint-Priest-en-Jarez, 42270
Marine-Alexia Lefevre, MD, 33 (0)6 86 47 32 07, marine-alexia.lefevre@inserm.fr
Belgium1 site, 1 recruiting
- Recruiting
Clinique universitaire Saint Luc
Brussels
Anne Herman, MD, 02/ 764 14 72, anne.herman@uclouvain.be
Marie Baeck, MD, 02/ 687 73 47, Marie.baeck@uclouvain.be
About this study
Official title: The Value of Molecular Signatures in the Diagnosis of Allergic Contact Dermatitis.
Allergic contact dermatitis (ACD) is a common inflammatory skin disease, which represents a major public health issue in industrialized countries. ACD is induced by repeated contact of individuals with environmental chemicals and is characterized by a delayed type IV hypersensitivity response with skin inflammation mediated by allergen-specific T cells in sensitized individuals.
The current diagnosis is based on clinical examination, assessment of environmental exposures and patch testing. Although the robustness of patch tests has long been established, this method can sometimes give inconclusive results, leading to problems in disease management.
Read more
Preliminary results indicate that the molecular analysis of Patch-Tests (PT) reactions could allow a more reliable diagnosis. Importantly, this gene profiling approach may help to identify patients with false positive PT reactions, i.e. patients whose PT reactions did not show any "allergy signature".
However, it remains to be demonstrated that the presence or absence of allergy biomarkers in PT lesions are indeed predictive of ACD response in patients.
The main objective is to describe the correlation between these molecular signatures and the reactivity of individuals when they are exposed to allergenic compounds under conditions of use (using ROAT test).
- Conditions
- Eczema, Allergic Contact Eczema Nos
- Being tested
- Blood sample, Skin biopsies, ROAT test
- Medical subject headings
- Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleProcedure or surgery
A blood sample (48 ml) will be collected from each patient before performing the ROAT tests. This sample will be used to perform in vitro lymphocyte proliferation test, and cytokine measurements.
Skin biopsiesProcedure or surgery
2 skin biopsies will be performed at the inclusion: one from positive/doubtful patch test reaction and one from control patch test. In case of positive ROAT test, 2 additional biopsies will be collected: one from positive ROAT test reaction and one from control area. Molecular analysis will be performed.
ROAT testProcedure or surgery
ROAT test (repeated open application test) is a use test used to establish the clinical relevance of patch tests. Patients will be exposed to 3 solutions of increasing concentration containing the culprit allergen (nickel, limonene hydroperoxide or linalool hydroperoxide), as well as a solution containing the vehicle alone (control solution), 2 times a day for up to 21 days, in the absence of a reaction.
| Study group | Role | What they receive |
|---|---|---|
| Patient with patch test reactions | Experimental | Patient with at least one positive/doubtful patch test reaction for nickel, limonene hydroperoxide and/or linalool hydroperoxide Receives: Procedure: Blood sample; Procedure: Skin biopsies; Procedure: ROAT test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression levels of allergy biomarkers
Expressed as fold change (ratio between gene expression levels in lesional skin of patch test reaction and their expression levels in healthy skin = control patch test, of the same patient) in patients with positive or negative ROAT test (Gold standard)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start20 Jun 2023
- Primary completion20 Mar 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for EczemaStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124781
- Sponsor's protocol ID
- 2021-A00231-40
- Acronym
- SMECA
- Status last verified
- Nov 2023
- First submitted
- 26 Oct 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nosbaum A, Vocanson M, Rozieres A, Hennino A, Nicolas JF. Allergic and irritant contact dermatitis. Eur J Dermatol. 2009 Jul-Aug;19(4):325-32. doi: 10.1684/ejd.2009.0686.
PubMed 19447733Vocanson M, Hennino A, Chavagnac C, Saint-Mezard P, Dubois B, Kaiserlian D, Nicolas JF. Contribution of CD4(+ )and CD8(+) T-cells in contact hypersensitivity and allergic contact dermatitis. Expert Rev Clin Immunol. 2005 May;1(1):75-86. doi: 10.1586/1744666X.1.1.75.
PubMed 20477656Vocanson M, Hennino A, Rozieres A, Poyet G, Nicolas JF. Effector and regulatory mechanisms in allergic contact dermatitis. Allergy. 2009 Dec;64(12):1699-714. doi: 10.1111/j.1398-9995.2009.02082.x. Epub 2009 Oct 12.
PubMed 19839974Lefevre MA, Nosbaum A, Rozieres A, Lenief V, Mosnier A, Cortial A, Prieux M, De Bernard S, Nourikyan J, Jouve PE, Buffat L, Hacard F, Ferrier-Lebouedec MC, Pralong P, Dzviga C, Herman A, Baeck M, Nicolas JF, Vocanson M. Unique molecular signatures typify skin inflammation induced by chemical allergens and irritants. Allergy. 2021 Dec;76(12):3697-3712. doi: 10.1111/all.14989. Epub 2021 Jul 14.
PubMed 34174113Ljungberg Silic L, Lefevre MA, Bergendorff O, De Bernard S, Nourikyan J, Buffat L, Nosbaum A, Bruze M, Nicolas JF, Svedman C, Vocanson M. Gene profiling reveals a contact allergy signature in most positive Amerchol L-101 patch test reactions. Contact Dermatitis. 2022 Jul;87(1):40-52. doi: 10.1111/cod.14077. Epub 2022 Mar 25.
PubMed 35184302
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Molecular Signatures in the Diagnosis of Allergic Contact Dermatitis.
- ClinicalTrials.gov ID
- NCT06124781
- Acronym / sponsor ID
- SMECA / 2021-A00231-40
- Conditions
- Eczema, Allergic Contact Eczema Nos
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 20 Mar 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 9 Nov 2023 (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.
Allergic contact dermatitis (ACD) is a common inflammatory skin disease, which represents a major public health issue in industrialized countries. ACD is induced by repeated contact of individuals with environmental chemicals and is characterized by a delayed type IV hypersensitivity response with skin inflammation mediated by allergen-specific T cells in sensitized individuals.
The current diagnosis is based on clinical examination, assessment of environmental exposures and patch testing. Although the robustness of patch tests has long been established, this method can sometimes give inconclusive results, leading to problems in disease management.
Preliminary results indicate that the molecular analysis of Patch-Tests (PT) reactions could allow a more reliable diagnosis. Importantly, this gene profiling approach may help to identify patients with false positive PT reactions, i.e. patients whose PT reactions did not show any "allergy signature".
However, it remains to be demonstrated that the presence or absence of allergy biomarkers in PT lesions are indeed predictive of ACD response in patients.
The main objective is to describe the correlation between these molecular signatures and the reactivity of individuals when they are exposed to allergenic compounds under conditions of use (using ROAT test).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with patch test reactions | Experimental | Procedure: Blood sample, Procedure: Skin biopsies, Procedure: ROAT testPatient with at least one positive/doubtful patch test reaction for nickel, limonene hydroperoxide and/or linalool hydroperoxide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient, male or female, over 18 years of age.
- Patient with at least one positive/doubtful patch test reaction for nickel, limonene hydroperoxide and/or linalool hydroperoxide
- Patient agreeing to undergo skin biopsies and blood sampling
- Patient agreeing to non-identifying pictures being taken of lesions
- Patient available to carry out skin tests and their interpretation
Key exclusion criteria (11 listed)
- Patient with active dermatitis lesions on the forearm
- Patient with a history of allergic reaction to a local anesthetic product
- Patient with wound healing disorders (hypertrophic or keloids scars)
- Patient with hematological disorders
- Patient having topical treatments with corticosteroids or immunomodulators on the forearms during the 21 days prior to the start of the study
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 |
|---|---|---|
| Blood sampleA blood sample (48 ml) will be collected from each patient before performing the ROAT tests. This sample will be used to perform in vitro lymphocyte proliferation test, and cytokine measurements. | Procedure or surgery | Patient with patch test reactions |
| Skin biopsies2 skin biopsies will be performed at the inclusion: one from positive/doubtful patch test reaction and one from control patch test. In case of positive ROAT test, 2 additional biopsies will be collected: one from positive ROAT test reaction and one from control area. Molecular analysis will be performed. | Procedure or surgery | Patient with patch test reactions |
| ROAT testROAT test (repeated open application test) is a use test used to establish the clinical relevance of patch tests. Patients will be exposed to 3 solutions of increasing concentration containing the culprit allergen (nickel, limonene hydroperoxide or linalool hydroperoxide), as well as a solution containing the vehicle alone (control solution), 2 times a day for up to 21 days, in the absence of a reaction. | Procedure or surgery | Patient with patch test reactions |
Primary outcome
Expression levels of allergy biomarkers
Time frame: 1 month
Expressed as fold change (ratio between gene expression levels in lesional skin of patch test reaction and their expression levels in healthy skin = control patch test, of the same patient) in patients with positive or negative ROAT test (Gold standard)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Results publication: PubMed 19447733Nosbaum A, Vocanson M, Rozieres A, Hennino A, Nicolas JF. Allergic and irritant contact dermatitis. Eur J Dermatol. 2009 Jul-Aug;19(4):325-32. doi: 10.1684/ejd.2009.0686.
- Results publication: PubMed 20477656Vocanson M, Hennino A, Chavagnac C, Saint-Mezard P, Dubois B, Kaiserlian D, Nicolas JF. Contribution of CD4(+ )and CD8(+) T-cells in contact hypersensitivity and allergic contact dermatitis. Expert Rev Clin Immunol. 2005 May;1(1):75-86. doi: 10.1586/1744666X.1.1.75.
- Results publication: PubMed 19839974Vocanson M, Hennino A, Rozieres A, Poyet G, Nicolas JF. Effector and regulatory mechanisms in allergic contact dermatitis. Allergy. 2009 Dec;64(12):1699-714. doi: 10.1111/j.1398-9995.2009.02082.x. Epub 2009 Oct 12.
- Results publication: PubMed 34174113Lefevre MA, Nosbaum A, Rozieres A, Lenief V, Mosnier A, Cortial A, Prieux M, De Bernard S, Nourikyan J, Jouve PE, Buffat L, Hacard F, Ferrier-Lebouedec MC, Pralong P, Dzviga C, Herman A, Baeck M, Nicolas JF, Vocanson M. Unique molecular signatures typify skin inflammation induced by chemical allergens and irritants. Allergy. 2021 Dec;76(12):3697-3712. doi: 10.1111/all.14989. Epub 2021 Jul 14.
- Results publication: PubMed 35184302Ljungberg Silic L, Lefevre MA, Bergendorff O, De Bernard S, Nourikyan J, Buffat L, Nosbaum A, Bruze M, Nicolas JF, Svedman C, Vocanson M. Gene profiling reveals a contact allergy signature in most positive Amerchol L-101 patch test reactions. Contact Dermatitis. 2022 Jul;87(1):40-52. doi: 10.1111/cod.14077. Epub 2022 Mar 25.
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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 Hélène Barba contact
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample, Skin biopsies and ROAT test in people with Eczema and Allergic Contact Eczema Nos, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 5 sites in 2 countries.
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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-François Oudet (0683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression levels of allergy biomarkers (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06124781, which also lists 5 linked publications.
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 9 Nov 2023.