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Lichen Planus, Oral clinical trials

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NCT ID: NCT06327620 Recruiting - Lichen Planus Clinical Trials

Treatment Of Oral Lichen Planus

Start date: January 15, 2022
Phase: N/A
Study type: Interventional

This novel project aims to explore an alternative treatment for oral lichen planus (OLP), a challenging condition with limited therapeutic options. The proposed treatment involves the topical application of Daivobet ointment, a combination of calcipotriol (vitamin D analog) and betamethasone (corticosteroid), which has shown promising results in the treatment of psoriasis Vulgaris. The study will involve 15 patients aged 30-60 years with clinically confirmed intra-oral erosive lichen planus, some of whom have not responded to current therapies. Participants will apply Daivobet ointment three times daily for four weeks, with clinical assessments conducted at the beginning, and at the end of the second and fourth weeks. Inclusion criteria require the presence of bilateral oral erosive lichen planus lesions, with clinical and histopathological confirmation based on the World Health Organization's modified definition. Exclusion criteria include histological signs of dysplasia, use of drugs possibly causing lichenoid reactions, recent treatment for OLP, and hypersensitivity to the study drug. Clinical evaluations will employ a scoring system based on lesion characteristics, including ulceration, erythema, and reticulation, measured with a calibrated grid. Subjective responses will be assessed through discomfort scores on a visual analog scale, and a questionnaire will capture any adverse effects. Digital photographs will document visual changes, and incisional biopsies will be performed to confirm the diagnosis. The project aims to provide valuable insights into the efficacy and safety of the Daivobet ointment as a potential alternative treatment for oral lichen planus, offering hope for improved outcomes for patients suffering from this challenging condition.

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 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.

NCT ID: NCT06135259 Not yet recruiting - Oral Lichen Planus Clinical Trials

Topical Erythropoietin Hydrogel in Management of Oral Lichen Planus

Start date: May 20, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the clinical efficacy of erythropoietin gel containing a solution of 4000 units with triamcinolone acetonide 0.1% gel in the treatment of symptomatic oral lichen planus (OLP)

NCT ID: NCT06119672 Recruiting - Oral Lichen Planus Clinical Trials

Efficacy of Probiotic Capsules With Topical Clobetasol Propionate in OLP Treatment

Start date: May 1, 2023
Phase: Phase 3
Study type: Interventional

Oral lichen planus patients who will meet inclusion criteria will be divided into 2 groups -The intervention group (Group P): This group will be randomly allocated to take one capsule twice daily during meal time at morning and evening of probiotics complex obtained from Biovea for 4 -week study period. Moreover, patients in this group will be instructed to apply clobetasole propionate in orabase gel 2 times daily for 4 weeks. Patients will receive their supply of the gel and probiotics every 2 weeks. The control group (Group B): This group will be randomly allocated to apply clobetasol propionate in orabase gel 4 times daily after meal times and before sleeping for 4 weeks. At the 3rd week this group will be instructed to apply miconazole gel 4 times daily as a prophylaxis for two weeks. Salivary sample collection: Unstimulated salivary sample was collected from all participants twice , once at baseline and another time after 4 weeks from the study period. Saliva was collected in graduated clear test tubes to be used in the evaluation of candidal counts before and after treatment . Patient's visits was at baseline, 2 weeks and 4 weeks.