Investigating biomarkers in patients with lichen planus
Evaluation of the Clinical Specificity of Cellular and Molecular Biomarkers Identified in Patients With Lichen Planus
This study is trying to find specific immune cells in the blood of people with lichen planus to see if they are linked to HPV and can help improve diagnosis and understanding of the condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Pasteur Industry-sponsored |
| Locations | 6 sites (Besançon and 5 other locations) |
| Trial ID | NCT06451744 on ClinicalTrials.gov |
What this trial studies
This study focuses on lichen planus, a chronic inflammatory condition affecting skin and mucous membranes, characterized by specific immune cell activity. It aims to identify unique T cell receptor (TCR) clonotypes associated with human papillomavirus (HPV) that may play a role in the disease's development. By collecting blood samples and performing biopsies, the study seeks to enhance the understanding of lichen planus and improve diagnostic accuracy. The research is particularly relevant for patients at the time of diagnosis or during disease progression.
Who should consider this trial
Good fit: Ideal candidates include individuals newly diagnosed with lichen planus or experiencing a progressive episode of the disease without prior systemic treatment.
Not a fit: Patients with dermatosis localized exclusively in skin folds or on the face may not benefit due to the risk of scarring from biopsies.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods and targeted treatments for patients with lichen planus.
How similar studies have performed: Previous studies have identified TCR clonotypes in lichen planus, suggesting that this approach may yield valuable insights, although the specific methodology in this study is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Dermatosis exclusively localised in the skin folds or on the face (risk of scarring from biopsies)
Where this trial is running
Besançon and 5 other locations
- CHU de Besançon — Besançon, France (Recruiting)
- CHU Paris Seine-Saint-Denis- Hôpital Avicenne — Bobigny, France (Recruiting)
- Centre Medical de l'Institut Pasteur — Paris, France (Recruiting)
- Hôpital Saint-Louis — Paris, France (Recruiting)
- Hôpital Robert Debré, CHU de Reims — Reims, France (Recruiting)
- CHU de Rouen — Rouen, France (Recruiting)
Study contacts
- Principal investigator: Manuelle Vigiuer — CHU Reims Service de Dermatologie Avenue du Général Koenig 51092 Reims
- Study coordinator: Marie-Lise Gougeon
- Email: marie-lise.gougeon@pasteur.fr
- Phone: 1 40 66 97 87
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.