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Oral Lichen Planus clinical trials

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NCT ID: NCT06449248 Completed - Oral Lichen Planus Clinical Trials

Oral Lichen Planus and Systemical Oncological Comorbidities

Start date: January 2, 2023
Phase:
Study type: Observational

Lichen planus (LP) is a chronic mucocutaneous inflammatory disease of unknown etiology. In its oral variant, oral lichen planus (OLP) has a reported prevalence ranging from 0.5% to 2.2% in the general population. The disease typically occurs between the ages of 30 and 60. Although the pathogenetic mechanism and the triggering factor remain unknown, an immune-mediated pathogenesis and the role of factors such as stress, anxiety, diabetes, other autoimmune diseases, hypertension, intestinal pathologies, chronic liver diseases, hypercholesterolemia, infections have been hypothesized , contact with dental materials, tumors and genetic predisposition to cancer. Oral lichen planus is one of the potentially malignant disorders, showing a malignant transformation rate of 1.4%. A preliminary analysis conducted in our research center has shown a correlation between OLP and systemic tumors, both solid and haematological, involving areas not involved in lesions attributable to OLP. According to these data, the objective of the study is to evaluate whether there is an association between OLP and peripheral tumors, both solid and haematological. The primary objective will be to investigate the possible existence of a statistically significant association between OLP and the development of systemic oncological pathologies. Secondary objective will be to investigate the existence of an association between the various forms of OLP and specific oncological pathologies and to evaluate whether the presence of other systemic pathologies and lifestyle factors (diabetes, hypertension, chronic liver disease, smoking, alcohol, infection by HPV, HCV, etc ...) could influence such association (primary outcome). The objectives will be pursued through the analysis of data collected from the medical records of patients belonging to the General Dentistry and Orthodontic Outpatient Clinics at the "Agostino Gemelli" Teaching Hospital and in the Oral Pathology Outpatient Clinics of the other centers involved.

NCT ID: NCT06428630 Not yet recruiting - Oral Lichen Planus Clinical Trials

Systemic Absorption of Dexamethasone Oral Rinse in Patients With Oral Lichen Planus

Start date: September 1, 2024
Phase: Early Phase 1
Study type: Interventional

The objective of this study is to see the amount of systemic absorption of a standard dose of dexamethasone oral rinse for patients with symptomatic oral lichen planus (OLP) or oral lichenoid reactions (OLR) and healthy subjects (those who do not have OLP or OLR aka the control group).

NCT ID: NCT06332365 Completed - Oral Lichen Planus Clinical Trials

Evaluating Treatment Efficacy in Oral Lichen Planus: The Role of Salivary Biomarkers

salivaLichen
Start date: January 3, 2022
Phase: N/A
Study type: Interventional

Lichen planus, a chronic autoimmune mucocutaneous disorder, affects 0.5% to 2.2% of diverse populations. The treatment for oral lichen planus (OLP) includes a range of options, both topical and systemic therapies. Recent research has highlighted the potential of hyaluronic acid as a drug alternative, potentially offering effective management for OLP and alleviating the discomfort of this chronic condition. The objective was to assess the impact of topical hyaluronic acid on salivary oxidative stress markers in individuals suffering from oral lichen planus

NCT ID: NCT06325514 Not yet recruiting - Oral Cancer Clinical Trials

Artificial Intelligence Based Program to Classify Oral Cavity Findings Based on Clinical Image Analysis

Start date: April 1, 2024
Phase:
Study type: Observational

This study aims to develop an AI program that can classify oral findings into Normal/variation of normal or an oral disease by clinical photos analysis, aiding in lowering the percentages of false positive and false negative diagnosis of oral diseases.

NCT ID: NCT06321003 Recruiting - Oral Cancer Clinical Trials

SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography

SYMILIS OCT
Start date: March 13, 2024
Phase:
Study type: Observational

This clinical trial aims to assess the efficacy of Optical Coherence Tomography (OCT) in the early diagnosis of oral cancer. It focuses on Oral Potentially Malignant Disorders (OPMDs) as precursors to Oral Squamous Cell Carcinoma (OSCC). Despite the availability of oral screening, diagnostic delays persist, underscoring the importance of exploring non-invasive methodologies. The OCT technology provides cross-sectional analysis of biological tissues, enabling a detailed evaluation of ultrastructural oral mucosal features. The trial aims to compare OCT preliminary evaluation with traditional histology, considered the gold standard in oral lesion diagnosing. It seeks to create a database of pathological OCT data, facilitating the non invasive identification of carcinogenic processes. The goal is to develop a diagnostic algorithm based on OCT, enhancing its ability to detect characteristic patterns such as the keratinized layer, squamous epithelium, basement membrane, and lamina propria in oral tissues affected by OPMDs and OSCC. Furthermore, the trial aims to implement Artificial Intelligence (AI) in OCT image analysis. The use of machine learning algorithms could contribute to a faster and more accurate assessment of images, aiding in early diagnosis. The trial aims to standardize the comparison between in vivo OCT images and histological analysis, adopting a site-specific approach in biopsies to improve correspondence between data collected by both methods. In summary, the trial not only evaluates OCT as a diagnostic tool but also aims to integrate AI to develop a standardized approach that enhances the accuracy of oral cancer diagnosis, providing a significant contribution to clinical practice.

NCT ID: NCT06260904 Not yet recruiting - Oral Lichen Planus Clinical Trials

Efficacy and Safety of add-on Apremilast Versus add-on Methotrexate in Patients With Oral Lichen Planus

Start date: February 26, 2024
Phase: Phase 4
Study type: Interventional

Lichen planus is an inflammatory disorder of unknown aetiology affecting the stratified squamous epithelia, with an estimated global prevalence of 0.22 to 0.5 %. Oral mucosa (Oral Lichen Planus; OLP) is the most commonly affected region. Corticosteroids are the primary treatment of choice. A prolonged treatment with steroids is required for clinical improvement, which increases the chances of long-term adverse effects. So, there is a need for newer, effective treatment modalities, such as retinoids, methotrexate, Janus kinase inhibitors, PDE4 inhibitors, etc. Of these, methotrexate is a dihydrofolate reductase inhibitor that inhibits the replication and function of T and B lymphocytes. It has shown a good response to OLP (around 83%) in a study by Lajevardi et al. and can be considered a treatment option in patients with moderate to severe OLP. Apremilast is a drug with a novel immunomodulatory mechanism of action. It inhibits phosphodiesterase type IV, which increases levels of cyclic adenosine monophosphate (cAMP), thus activating protein kinase A and inhibiting various inflammatory mediators. Based on a pilot study by Paul et al., apremilast is associated with clinical improvement in lichen planus. Among the various treatment options, there is a lack of head-on trials. Methotrexate is an immunosuppressant with various systemic adverse effects and requires close monitoring. Whereas apremilast is a non-immunosuppressive drug with a better safety profile, it does not show such adverse effects. These drugs can be used as an add-on to low-dose steroids in view of reducing the adverse effects associated with steroid therapy. To the best of our knowledge, there is no randomized controlled trial comparing these two drugs to date. Hence, the present study has been planned to evaluate the safety and efficacy of methotrexate versus apremilast as an add-on to the standard steroid therapy in OLP patients.

NCT ID: NCT06233591 Not yet recruiting - Oral Lichen Planus Clinical Trials

Evaluating LP-10 in Subjects With OLP

Start date: March 1, 2024
Phase: Phase 2
Study type: Interventional

This is a multicenter, dose-ranging study including adult male and female subjects (>= 18 years old) with symptomatic Oral Lichen Planus (OLP). A total of approximately 24 subjects will be enrolled at approximately five (5) study sites in the United States. This study will evaluate the safety, tolerability and efficacy of LP-10 at 0.25 mg, 0.5 mg and 1.0 mg of tacrolimus.The study consists of screening, treatment and follow-up phases. The treatment phase includes 10 mL LP-10 oral rinse for 3 minutes twice a day for 4 weeks. The follow-up phase includes one post-treatment visit 2 weeks after the last oral LP-10 dose.

NCT ID: NCT06204796 Completed - Clinical trials for Vitamin D Deficiency

The Role of Vitamin D in Amelioration of Oral Lichen Planus and Its Effect on Salivary IFN-γ Level

Start date: August 1, 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to compare between the use of vitamin D supplement in conjunction with systemic steroids versus the use of systemic steroids alone in the management of patients with symptomatic Oral Lichen Planus lesions and the comparison of salivary Interferon gamma levels in both study groups before and after treatment

NCT ID: NCT06158113 Recruiting - Oral Lichen Planus Clinical Trials

Efficacy and Safety of Baricitinib in Oral Lichen Planus: a Proof-of-Concept Study

Start date: March 13, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to learn the effects of baricitinib (the study drug) in patients with Oral Lichen Planus. The main questions it aims to answer are: - What is the efficacy of baricitinib in treating moderate to severe Oral Lichen Planus? - Can baricitinib treatment in Oral Lichen Planus change quality of life? - What side effects do patients with Oral Lichen Planus experience when treated with baricitinib? Participants will be required to come in to monthly visits for up to eight months. During visits, participants will be: - Evaluated for the extent of their disease - Asked to fill out a questionnaire about their quality of life - Given baricitinib for them to take at home for six months - Evaluated for any potential side experienced while on treatment - Asked to return 1 month after completing treatment

NCT ID: NCT06135805 Recruiting - Oral Lichen Planus Clinical Trials

Impact of Fluocinonide 0,05% in Oral Lichen Planus

Start date: October 27, 2020
Phase: N/A
Study type: Interventional

A double-blind placebo-controlled trial is conducted in order to evaluate the efficacy of Fluocinonide 0,05% and determinate the statistical significance of the outcome variables. Oral cavity lichen is a chronic inflammatory condition affecting the mucosa of the oral cavity , which significantly reduces the quality of life of affected individuals.