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Oral Lichen Planus clinical trials

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NCT ID: NCT04364555 Recruiting - Oral Lichen Planus Clinical Trials

Efficacy of Topical Treatment With Clobetasol in Symptomatic Oral Lichen Planus.

Start date: May 18, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The investigators want to study the effect of clobetasol in symptomatic oral lichen planus. The investigators will include 90 patients and randomly allocate them in three groups. The first group will receive active treatment both in the morning an evening. Group two receives placebo in the morning and active treatment in the evening. Group three will get placebo both in the morning and in the evening. All Groups will follow the same protocol with rinsing twice daily with test substance in conjunction with antifungal treatment. The patients will be controlled after two weeks and and again after another two weeks. A biopsy will be performed at inclusion and another biopsy will be taken at the end of the test period. Smears for candida will also be evaluated. The patients will be examined for changes in clinical appearance and will answer questions to note changes in symptoms. Our hypotheses: #Patients receiving clobetasol will have a better resolution af symptoms than those who got placebo. #Patients treated with clobetasol twice daily will have a faster relief of symptoms than patients just treated once daily. #The clinical signs of oral lichen planus will diminish more pronounced in the two groups given active treatment. #A majority of the OLP lesions were infected by candida. #Specific histological changes can be seen in the biopsies taken after clobetasol treatment compared to those taken before treatment.

NCT ID: NCT04278599 Recruiting - Oral Lichen Planus Clinical Trials

Effect of Oral Zinc Supplementation as an Adjuvant to Topical Corticosteroid in Oral Lichen Planus Patients

Start date: January 15, 2020
Phase: Phase 4
Study type: Interventional

Lichen planus is an auto-immune, chronic inflammatory disease that affects mucosal and cutaneous tissue. Erosive and atrophic oral lichen planus (OLP) are difficult to manage because patients present with symptoms ranging from episodic pain to severe discomfort and they have the highest malignant transformation rate (MTR) amongst all the forms of OLP. Zinc is associated with regeneration of epithelium, wound healing and mediating T-lymphocyte function; all of which can lead to healing and re-epithelisation in the lesions of erosive OLP. Besides this, it also has anti-oxidant and anti-inflammatory properties, which lead to decrease in apoptosis and transformation into a malignant state. This study intends to evaluate the effect of oral zinc supplements as an adjuvant to the topical corticosteroid therapy in the treatment of OLP.

NCT ID: NCT03975322 Recruiting - Oral Lichen Planus Clinical Trials

Prediction of Malignant Transformation of Oral Leukoplakia Using a MAGE-A-based Immunoscore

PREDICT-OLP
Start date: December 1, 2019
Phase:
Study type: Observational [Patient Registry]

Oral squamous cell carcinomas (OSCC) is among the most common malignancies worldwide. Early detection and prevention of OSCC is thought to have the highest potential to reduce morbidity and mortality. In prevention, the main focus is on precancerous lesions, especially oral leukoplakia (OLP), as up to 67% of OSCC arise on the basis of OLP. The determination of the transformation risk of OLP by histological determination of the degree of dysplasia is unreliable. A promising marker for the timely development of a OSCC is the detection of antigens of the MAGE-A gene family. The special feature of MAGE-A is that they can be detected in 93% of all OSCC and in approx. 85% of OLP that transform to OSCC. The detection of MAGE-A could also indicate changes in the immunological environment that occur prior to malignant OLP transformation and could be used for immunotherapies. Aim of this study is to investigate MAGE-A as a predictive marker for the malignant transformation of OLP in the setting of a prospective, multicenter study and to establish it as a diagnostic parameter in addition to classical histology. In addition, the association of MAGE-A expression with the occurrence of immunological changes in OLP will be investigated in order to evaluate the possibility of minimally invasive immunotherapy of OLP. The study is intended to include 500 biopsies of non-selected patients with OLP from university institutions and private practices. The follow-up should be at least 3 years, whereby it is examined whether an OSCC on the basis of the original OLP developed. After three years, an interim evaluation of the results with statistical evaluation will be carried out. In order to ensure that the course of the disease is monitored for at least three years for all OLPs, an extension of the monitoring period to 5 years is planned. The study could establish a routine diagnostic parameter to supplement the histo-morphological diagnosis of OLP and evaluate the possibility of immunotherapy of OLP.

NCT ID: NCT03415165 Recruiting - Oral Lichen Planus Clinical Trials

Efficacy of Green Tea Buccal Tablets in Oral Lichen Planus

Start date: January 3, 2018
Phase: Early Phase 1
Study type: Interventional

Is topical application of green tea polyphenols buccal tablet more effective in treatment of patients with symptomatic oral lichen planus in comparison with topical application of corticosteroids and what is the most effective concentration of polyphenols

NCT ID: NCT03237533 Recruiting - Oral Lichen Planus Clinical Trials

Treatment Modalities of Oral Lichen Planus

OLP
Start date: June 1, 2017
Phase: Early Phase 1
Study type: Interventional

Background: Oral lichen planus (OLP) is a chronic inflammatory mucocutaneous autoimmune disease mainly affecting stratum basal of the epithelium. It is very painful and hamper the daily routine of patients e.g. (talking, drinking, eating, maintaining normal relationships). Different topical treatments have been tried for the symptomatic relief of OLP which include topical corticosteroids (TCSs), topical calcineurin inhibitors (TCIs) retinoids, photochemotherapy; amitryptaline; thalidomide; amlexanox and traditional medicines such as curcumin, selenium-ACE combined with itraconazole, glycyrrhiza glabra and aloe vera. But the exact treatment is still unknown. Objective: To compare the efficacy of Dexamethasone, Doxycycline, Nystatin and Promethazine cocktail with Triamcinolone as topical treatment of OLP Subjects and Methods: 40 patients of symptomatic OLP will be randomly divided in to study and control group. Study group will be given a cocktail containing dexamethasone, doxycycline, nystatin and promethazine and will be advised to rinse with 1 and half teaspoon of this cocktail 3 times a day for 2 minutes for the period of 8 weeks. Study group is also advised to apply an orabase containing 0.1% triamcinolone on lesions 3 times a day for the period of 8 weeks. The control group will be advised to apply only triamcinolone orabase 3 times a day for 8 weeks.

NCT ID: NCT03026478 Recruiting - Oral Lichen Planus Clinical Trials

Topical Betamethasone and Clobetasol in Orabase in Oral Lichen Planus

Start date: May 6, 2016
Phase: Phase 2
Study type: Interventional

Oral Lichen Planus (OLP) is an autoimmune, chronic inflammatory mucocutaneous disease characterized by pain and burning sensation. The major types of OLP are the following: reticular, atrophic, erosive-ulcerative, bullous and pigmentous form.Its etiology remains unclear. The presence of auto-cytotoxic T cell clones in the lesions suggests the role of autoimmunity. Numerous treatment options of OLP include topical and systemic agents depending on severity of lesions . Topical corticosteroids abide the mainstay of therapy,and are widely accepted as the primary treatment of choice.Hence this study is designed to evaluate and compare the clinical efficacy of topical Clobetasol 0.05% in orabase and Betamethasone 0.05% in orabase in combination with Clotrimazole 1% in the management of symptomatic Oral Lichen Planus.

NCT ID: NCT00737854 Recruiting - Oral Lichen Planus Clinical Trials

Free Soft Tissue Graft in Treatment of Oral Lichen Planus

TOLP
Start date: May 2008
Phase: Phase 1
Study type: Interventional

Oral lichen planus is a common chronic mucocutaneous disease with various clinical forms. Erosive-ulcerative forms usually cause symptoms of pain and discomfort. The most important complication of OLP is development of oral squamous cell carcinoma, although this is a very controversial matter. various treatments have been suggested for OLP but their results are unsatisfactory. Through the experiences of the investigators, corticosteroids (in any form)is not a wise option for treating OLP and has many side effects . More over, immunosuppressive therapy did not influence the risk for oral cancer. The purpose of the study is to determine the efficacy of free soft tissue graft in the treatment of precancerous and symptomatic lesions of OLP. Removal of the lesions up to submucosa has been done. The graft sliced from healthy mucosa also up to submucosa. Then graft will be sutured in position. According to other authors, basal epithelial layers of the graft remain intact and represent the focus of re-epithelization. New epithelial cells migrate over the basal membrane and appear to guide it by proliferation, will generate new epithelium. The wound is re-epithelialized by proliferation of surrounding healthy epithelial cell, therefore, not contaminated by modified antigens of the cell membrane that are theoretically responsible for lymphocyte aggression. The healthy graft remains free of lesions and appears clinically healthy.