An interventional study of Blood samples collection and Skin or mucous membrane brushing in Lichen Planus, sponsored by Institut Pasteur. Recruiting at 6 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-01.
Sponsored by Institut Pasteur · Not applicable, Interventional, and Diagnostic
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.
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.
74 studies on the registry are indexed under Lichen Planus; 15 are open to participants now.
This study's planned enrollment of 70 is above the median of 30 across 55 interventional studies indexed under Lichen Planus.
Browse Lichen Planus studies →Institut Pasteur is the lead sponsor of 99 studies on the registry; 41 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Other: Blood samples collection · Other: Skin or mucous membrane brushing · Other: Skin or mucous membrane biopsy
Human biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1
Other: Blood samples collection · Other: Skin or mucous membrane brushing
Human biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1
Other: Blood samples collection · Other: Skin or mucous membrane brushing
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
Other: Blood samples collection · Other: Skin or mucous membrane brushing · Other: Skin or mucous membrane biopsy
Human biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1
Other: Blood samples collection · Other: Skin or mucous membrane brushing
Human biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1
Other: Blood samples collection · Other: Skin or mucous membrane brushing
Human biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1
Other: Blood samples collection · Other: Skin or mucous membrane brushing
50 mL blood sample
brushing on skin or mucous membrane lesions
6 mm biopsy
Identification of TCR repertoire by flow cytometry
Determination by flow cytometry and PCR testing for TCR repertoire bias
Time frame: 3 years
Identification of characteristic biomarkers of lichen
Identify complementary biomarkers characterising lichen by quantitative PCR
Time frame: 3 years
Identification of T CD8 clonotypes
Measurement of the antigenic specificity of identified T CD8 clonotypes by flow cytometry
Time frame: 3 years
Plan to share: No
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