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Lichen Planus, Oral clinical trials

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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.

NCT ID: NCT00656214 Completed - Lichen Planus, Oral Clinical Trials

Treatmant of Oral Lichen Planus With Lycopene

Start date: December 2004
Phase: Phase 2
Study type: Interventional

the purpose of this study was to evaluate that if lycopene, a potent antioxidant can be used in the treatment of oral lichen planus. this could be useful as lycopene has no reported side effects and hence it can used in place of steroids which are commonly used for this condition and have many reported adverse effects. lycopene can be used in the treatment of this condition as free radicals have been found to play a role in the cause of this disease and also lower levels of lycopene were seen in these patints.

NCT ID: NCT00525421 Completed - Oral Lichen Planus Clinical Trials

A Clinical Study of Curcuminoids in the Treatment of Oral Lichen Planus

Start date: October 2007
Phase: Phase 2
Study type: Interventional

A phase 2 randomized, placebo-controlled, double-blind trial of a two week course of curcuminoids in oral lichen planus will be conducted. 26 consecutive, eligible patients with OLP presenting to the oral medicine clinic at the University of California, San Francisco, will be enrolled. Study subjects will be randomized to receive either placebo or curcuminoids 6000mg/day for 2 weeks in three divided doses of 2000mg three times/day. Measurement of signs, symptoms, periodontal status and blood tests including complete blood count, liver enzymes, serum c reactive protein and serum interleukin-6 levels will be done at baseline and at the end of 2 weeks. A side-effects questionnaire will be administered at the 2-week follow-up. The Numeric Rating Scale (NRS) will be used to measure symptoms and the Modified Oral Mucositis Index (MOMI) to measure clinical signs of OLP. Primary outcome is change in symptoms from baseline. Secondary outcomes are change in clinical signs, occurrence of side-effects, change in serum C-reactive protein and serum interleukin-6 levels.

NCT ID: NCT00484250 Completed - Oral Lichen Planus Clinical Trials

Study of Metronidazole and Doxycycline to Treat Oral Lichen Planus and to Compare Their Efficacy With Each Other

Start date: September 2005
Phase: Phase 2
Study type: Interventional

Oral lichen planus (OLP) is a chronic inflammatory disorder which causes local irritation,discomfort and subsequent poor dentition and discomfort in eating . Various treatments have been suggested for OLP but their results are unsatisfactory .Despite the fact that steroids have been the main therapeutic choice for many years,some researches have been done regarding the efficacy of other medication such as metronidazole and doxycycline.The purpose of this study is to determine whether metronidazole and doxycycline are effective in the treatment of oral lichen planus and to compare their efficacy with each other.

NCT ID: NCT00297037 Completed - Oral Lichen Planus Clinical Trials

Pimecrolimus Cream for Oral Lichen Planus

Start date: August 2005
Phase: Phase 2
Study type: Interventional

Study investigating the use of pimecrolimus 1% cream for oral lichen planus

NCT ID: NCT00226174 Terminated - Oral Lichen Planus Clinical Trials

A Randomized, Placebo-controlled, Double-blind Clinical Trial of Curcuminoids in Oral Lichen Planus

Start date: February 2003
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether curcuminoids are effective in the treatment of oral lichen planus.

NCT ID: NCT00133107 Completed - Lichen Planus, Oral Clinical Trials

Safety and Effectiveness of Efalizumab to Treat Oral Lichen Planus

Start date: January 2005
Phase: N/A
Study type: Interventional

This study is to determine whether efalizumab 1.0mg/kg given by subcutaneous injection for 12 weeks is effective in treating oral lichen planus. This is a 20 week, single center, open-label pilot study to enroll 5 subjects.

NCT ID: NCT00130572 Completed - Lichen Planus, Oral Clinical Trials

Efficacy of Elidel Cream on Erosive Oral Lichen Planus

Start date: June 2004
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate whether topical applied pimecrolimus will lead to improvement of erosive oral lichen planus. This effect will be monitored by reduction of erosive mucosal area and reduction of patient's pain symptoms.

NCT ID: NCT00111072 Completed - Oral Lichen Planus Clinical Trials

Dexamethasone to Treat Oral Lichen Planus

Start date: May 2005
Phase: Phase 2
Study type: Interventional

This study will evaluate the effectiveness of dexamethasone 0.01% solution in treating pain associated with oral lichen planus, a chronic disease that causes painful ulcers inside the mouth. The cause of lichen planus not known, but it may be related to an allergic or immune reaction. This study will examine what causes the disease, the pain associated with it, its impact on patients' lives and the use of dexamethasone to treat it. Patients 12 or older with severe oral lichen planus may be eligible for this study. Candidates are screened with blood tests and a biopsy to confirm the diagnosis and provide tissues for research purposes. For the biopsy, two small circles of tissue, each about 4 mm (1/5 inch) across, are surgically removed. Participants are randomly assigned to rinse their mouth with either a dexamethasone solution or placebo (a rinse with no active ingredient) four times a day for 4 weeks. During this period they may not use any oral or topical pain or anti-inflammatory medications except diphenhydramine 12.5 mg/5 ml (a topical numbing medicine) and Tylenol, both which are provided by the study. Patients come to the NIH Clinical Center for three 1-hour visits (once every two weeks) and once more 4 weeks after the study medications are stopped. At the first three visits patients submit a pain diary in which they have recorded information on pain levels, and they are checked for any medication side effects. On the third visit (the last day they take the study drug) they are also tested for adrenal suppression that may have resulted from taking the steroid rinse. For this test they are given an injection of a drug called synacthen and after 1 hour, a blood sample is drawn. Patients return for a final visit 1 month later to determine if their disease returns or improves after the medication is stopped.

NCT ID: NCT00102557 Completed - Lichen Planus, Oral Clinical Trials

Hydroxychloroquine vs. Clobetasol Rinse to Treat Oral Lichen Planus

Start date: January 2005
Phase: Phase 2
Study type: Interventional

This study will compare two treatments for oral lichen planus - hydroxychloroquine (Plaquenil) tablets and clobetasol oral rinse. Oral lichen planus is a chronic disorder in which patients have painful mouth ulcers that interfere with meals and daily functioning. It is most commonly treated with topical or systemic corticosteroids, but these drugs have a number of side effects, most commonly yeast infection, and chronic systemic use of them can lead to diabetes, osteoporosis, weight gain, and other complications. Also, lichen planus generally returns when the corticosteroids are stopped. Clobetasol oral rinse is a topical steroid commonly used to treat oral lichen planus. Hydroxychloroquine, a drug that was originally used to treat malaria and is now also approved for lupus and rheumatoid arthritis, has been tried for lichen planus in small-scale studies with some evidence of benefit. Patients 18 years of age and older with oral lichen planus may be eligible for this study. Pregnant women are excluded. Candidates are screened with a dermatology examination, routine blood tests, an eye examination, and a biopsy to rule out other conditions similar to lichen planus and to provide tissue for research purposes. For the biopsy, two small circles of tissue about 4 mm (less than 1/5") across are surgically removed from the area with lichen planus. Participants are randomly assigned to treatment with either hydroxychloroquine or clobetasol rinse. Patients assigned to hydroxychloroquine also take a placebo mouth rinse that looks and tastes like the clobetasol rinse, and those assigned to clobetasol also take a pill that looks and tastes like the hydroxychloroquine tablet. This is done so that neither the patients nor the study doctors know which patient is taking which active medication until the study is completed. Patients take the pills daily in the morning with food or a glass of milk for the 6-month study period and use the rinse twice a day for 4 months and then once a day for 2 months. They may not use any pain or anti-inflammatory medicines or topical creams, gels or rinses regularly, because these medications can obscure the effects of the study drugs and complicate interpretation of the results. They are given a topical numbing medicine as part of the study and can use Tylenol for pain during the study duration. In addition to treatment, participants visit the NIH Clinical Center once a month for the following tests and procedures: - Review of pain levels, as recorded in a pain diary - Review of drug side effects, if any - Collection of saliva and blood samples at 2, 4 and 6 months - Repeat oral biopsy at completion of the study at 6 months to evaluate treatment effects - Final examination at 8 months to determine if the disease returns or improves after the medication is stopped.