Lichen PlanusHELPNCT06451744
Cellular and Molecular Biomarkers in Patients With Lichen Planus
A study testing Blood samples collection, Skin or mucous membrane brushing and Skin or mucous membrane biopsy in people with Lichen Planus, run by Institut Pasteur at 6 sites in France.
Trial summary
Lichen planus (LP) is a chronic inflammatory disease of unknown aetiology, affecting the skin and mucous membranes, characterised by a CD8+ cytotoxic T-cell infiltrate, associated with epithelial cell death and disruption of the basement membrane zone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lichen Planus
- What is being tested?
- Blood samples collection, Skin or mucous membrane brushing and Skin or mucous membrane biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 6 sitesFrance
- Study dates
- 1 Nov 2023to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Subject coming at the time of diagnosis of the disease before any systemic treatment, or at the time of a progressive episode of the disease, without systemic treatment or after cessation of immunomodulatory or immunosuppressive treatment
- Ability to give their consent in writing
- Must understand spoken and written French
- Affiliated to the French social security or assimilated regimes
Who cannot join
- Dermatosis exclusively localised in the skin folds or on the face (risk of scarring from biopsies)
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
CHU de Besançon
Besançon, 25030
François Aubin, Pr
- Recruiting
CHU Paris Seine-Saint-Denis- Hôpital Avicenne
Bobigny
Frédéric Caux, Pr
- Recruiting
Centre Medical de l'Institut Pasteur
Paris, 75015
Fabien Taieb, Dr, +33145688088, fabien.taieb@pasteur.fr
- Recruiting
Hôpital Saint-Louis
Paris
Hervé Bachelez, Pr
Jean-David Bouaziz
- Recruiting
Hôpital Robert Debré, CHU de Reims
Reims, 51092
Manuelle Viguier, Pr
- Recruiting
CHU de Rouen
Rouen
Pascal Joly, Pr
About this study
Official title: Evaluation of the Clinical Specificity of Cellular and Molecular Biomarkers Identified in Patients With Lichen Planus
Lichen planus (LP) is a chronic inflammatory disease of unknown aetiology, affecting the skin and mucous membranes, characterised by a CD8+ cytotoxic T-cell infiltrate, associated with epithelial cell death and disruption of the basement membrane zone. In previous work, T cell antigen receptor (TCR) repertoire studies were performed. In all patients tested, whether with erosive or non-erosive LP, unique nucleotide sequences, called clonotypes, have been identified. They appear during the process of TCR gene rearrangement. These clonotypes are specific for human papillomavirus (HPV) in blood and lesions, suggesting antigenic stimulation of these clonotypes by a viral epitope of HPV, which crosses with an epitope on keratinocytes. The diagnosis of LP is made on the basis of clinical and histological criteria, but in some patients and in some anatomical locations, the diagnosis is difficult to make and LP may be confused with other skin conditions.
Read the detailed description
Lichen planus (LP) is a chronic inflammatory disease of unknown aetiology, affecting the skin and mucous membranes, characterised by a CD8+ cytotoxic T-cell infiltrate, associated with epithelial cell death and disruption of the basement membrane zone. Several triggers have been proposed for LP, including viral antigens. In previous work, T cell antigen receptor (TCR) repertoire studies were performed, i.e. investigating the diversity of TCRs expressed on the surface of an individual's lymphocyte population. In all patients tested, whether with erosive or non-erosive LP, unique nucleotide sequences, called clonotypes, have been identified. They appear during the process of TCR gene rearrangement. These clonotypes are specific for human papillomavirus (HPV) in blood and lesions, suggesting antigenic stimulation of these clonotypes by a viral epitope of HPV, which crosses with an epitope on keratinocytes. The diagnosis of LP is made on the basis of clinical and histological criteria, but in some patients and in some anatomical locations, the diagnosis is difficult to make and LP may be confused with other skin conditions.
- Conditions
- Lichen Planus
- Being tested
- Blood samples collection, Skin or mucous membrane brushing, Skin or mucous membrane biopsy
- Medical subject headings
- Lichen Planus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples collectionOther
50 mL blood sample
Skin or mucous membrane brushingOther
brushing on skin or mucous membrane lesions
Skin or mucous membrane biopsyOther
6 mm biopsy
| Study group | Role | What they receive |
|---|---|---|
| Oral lichen planus erosive | Experimental | Human biological samples :
* blood samples collection at visit 1 and 2 (6 month after first visit)
* brushing on skin or mucous membrane lesions at visit 1
* skin or mucous membrane biopsy at visit 1 and 2 Receives: Other: Blood samples collection; Other: Skin or mucous membrane brushing; Other: Skin or mucous membrane biopsy |
| mucosal pemphigoid with oral lesions | Experimental | Human biological samples :
* blood samples collection at visit 1
* brushing on skin or mucous membrane lesions at visit 1 Receives: Other: Blood samples collection; Other: Skin or mucous membrane brushing |
| lichen planus with scalp involvement | Experimental | Human biological samples :
* blood samples collection at visit 1
* brushing on skin or mucous membrane lesions at visit 1 Receives: Other: Blood samples collection; Other: Skin or mucous membrane brushing |
| Pseudopelade of Brocq | Experimental | Human biological samples :
* blood samples collection at visit 1
* brushing on skin or mucous membrane lesions at visit 1
* skin or mucous membrane biopsy at visit 1 Receives: Other: Blood samples collection; Other: Skin or mucous membrane brushing; Other: Skin or mucous membrane biopsy |
| lichen planus with nail involvement | Experimental | Human biological samples :
* blood samples collection at visit 1
* brushing on skin or mucous membrane lesions at visit 1 Receives: Other: Blood samples collection; Other: Skin or mucous membrane brushing |
| psoriasis and specific nail involvement | Experimental | Human biological samples :
* blood samples collection at visit 1
* brushing on skin or mucous membrane lesions at visit 1 Receives: Other: Blood samples collection; Other: Skin or mucous membrane brushing |
| Lichenoid graft-versus-host disease | Experimental | Human biological samples :
* blood samples collection at visit 1
* brushing on skin or mucous membrane lesions at visit 1 Receives: Other: Blood samples collection; Other: Skin or mucous membrane brushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of TCR repertoire by flow cytometry
Determination by flow cytometry and PCR testing for TCR repertoire bias
Measured: 3 years
Secondary outcomes (2)
Identification of characteristic biomarkers of lichen
Identify complementary biomarkers characterising lichen by quantitative PCR
Measured: 3 years
Identification of T CD8 clonotypes
Measurement of the antigenic specificity of identified T CD8 clonotypes by flow cytometry
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Nov 2023
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lichen PlanusStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manuelle Vigiuer, Principal investigator, CHU Reims Service de Dermatologie Avenue du Général Koenig 51092 Reims
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451744
- Sponsor's protocol ID
- 2021-048
- Acronym
- HELP
- Status last verified
- Jun 2025
- First submitted
- 6 Jul 2023
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Specificity of Cellular and Molecular Biomarkers Identified in Patients With Lichen Planus
- ClinicalTrials.gov ID
- NCT06451744
- Acronym / sponsor ID
- HELP / 2021-048
- Conditions
- Lichen Planus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 11 Jun 2024 (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.
Lichen planus (LP) is a chronic inflammatory disease of unknown aetiology, affecting the skin and mucous membranes, characterised by a CD8+ cytotoxic T-cell infiltrate, associated with epithelial cell death and disruption of the basement membrane zone. In previous work, T cell antigen receptor (TCR) repertoire studies were performed. In all patients tested, whether with erosive or non-erosive LP, unique nucleotide sequences, called clonotypes, have been identified. They appear during the process of TCR gene rearrangement. These clonotypes are specific for human papillomavirus (HPV) in blood and lesions, suggesting antigenic stimulation of these clonotypes by a viral epitope of HPV, which crosses with an epitope on keratinocytes. The diagnosis of LP is made on the basis of clinical and histological criteria, but in some patients and in some anatomical locations, the diagnosis is difficult to make and LP may be confused with other skin conditions.
Detailed description
Lichen planus (LP) is a chronic inflammatory disease of unknown aetiology, affecting the skin and mucous membranes, characterised by a CD8+ cytotoxic T-cell infiltrate, associated with epithelial cell death and disruption of the basement membrane zone. Several triggers have been proposed for LP, including viral antigens. In previous work, T cell antigen receptor (TCR) repertoire studies were performed, i.e. investigating the diversity of TCRs expressed on the surface of an individual's lymphocyte population. In all patients tested, whether with erosive or non-erosive LP, unique nucleotide sequences, called clonotypes, have been identified. They appear during the process of TCR gene rearrangement. These clonotypes are specific for human papillomavirus (HPV) in blood and lesions, suggesting antigenic stimulation of these clonotypes by a viral epitope of HPV, which crosses with an epitope on keratinocytes. The diagnosis of LP is made on the basis of clinical and histological criteria, but in some patients and in some anatomical locations, the diagnosis is difficult to make and LP may be confused with other skin conditions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Oral lichen planus erosive | Experimental | Other: Blood samples collection, Other: Skin or mucous membrane brushing, Other: Skin or mucous membrane biopsyHuman biological samples : * blood samples collection at visit 1 and 2 (6 month after first visit) * brushing on skin or mucous membrane lesions at visit 1 * skin or mucous membrane biopsy at visit 1 and 2 |
| mucosal pemphigoid with oral lesions | Experimental | Other: Blood samples collection, Other: Skin or mucous membrane brushingHuman biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1 |
| lichen planus with scalp involvement | Experimental | Other: Blood samples collection, Other: Skin or mucous membrane brushingHuman biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1 |
| Pseudopelade of Brocq | Experimental | Other: Blood samples collection, Other: Skin or mucous membrane brushing, Other: Skin or mucous membrane biopsyHuman biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1 * skin or mucous membrane biopsy at visit 1 |
| lichen planus with nail involvement | Experimental | Other: Blood samples collection, Other: Skin or mucous membrane brushingHuman biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1 |
| psoriasis and specific nail involvement | Experimental | Other: Blood samples collection, Other: Skin or mucous membrane brushingHuman biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1 |
| Lichenoid graft-versus-host disease | Experimental | Other: Blood samples collection, Other: Skin or mucous membrane brushingHuman biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject coming at the time of diagnosis of the disease before any systemic treatment, or at the time of a progressive episode of the disease, without systemic treatment or after cessation of immunomodulatory or immunosuppressive treatment
- Ability to give their consent in writing
- Must understand spoken and written French
- Affiliated to the French social security or assimilated regimes
Key exclusion criteria (1 listed)
- Dermatosis exclusively localised in the skin folds or on the face (risk of scarring from biopsies)
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 samples collection50 mL blood sample | Other | Lichenoid graft-versus-host disease, Oral lichen planus erosive, Pseudopelade of Brocq, lichen planus with nail involvement, lichen planus with scalp involvement, mucosal pemphigoid with oral lesions, psoriasis and specific nail involvement |
| Skin or mucous membrane brushingbrushing on skin or mucous membrane lesions | Other | Lichenoid graft-versus-host disease, Oral lichen planus erosive, Pseudopelade of Brocq, lichen planus with nail involvement, lichen planus with scalp involvement, mucosal pemphigoid with oral lesions, psoriasis and specific nail involvement |
| Skin or mucous membrane biopsy6 mm biopsy | Other | Oral lichen planus erosive, Pseudopelade of Brocq |
Primary outcome
Identification of TCR repertoire by flow cytometry
Time frame: 3 years
Determination by flow cytometry and PCR testing for TCR repertoire bias
2 secondary outcomes
Identification of characteristic biomarkers of lichen
Time frame: 3 years
Identification of T CD8 clonotypes
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Lichen Planus
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Not yet recruiting
Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
Oral Lichen Planus
Not yet recruiting
Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
Degree of Adherence of Symptomatic OLP Patients to Their Medications
RecruitingPhase 2
A Study to Assess the Efficacy and Safety of GIA632 Across a Range of Doses in Participants With Moderate to Severe Cutaneous Lichen Planus
Cutaneous Lichen Planus
RecruitingPhase 2
Upadacitinib in Adult Patients With Erosive Mucosal Lichen Planus and Lichen Planopilaris: a Prospective Multicenter Randomized Placebo-controlled Study.
Lichen Penis Planus
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.
Manuelle Vigiuer principal investigator
CHU Reims Service de Dermatologie Avenue du Général Koenig 51092 Reims
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples collection, Skin or mucous membrane brushing and Skin or mucous membrane biopsy in people with Lichen Planus, run by Institut Pasteur at 6 sites 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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Lise Gougeon (1 40 66 97 87, marie-lise.gougeon@pasteur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of TCR repertoire by flow cytometry (time frame: 3 years). 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 1 Jul 2025.