Chamaemelum Nobile 2% Versus Placebo Topic Gel to Treat Oral Lichen Planus

Study Overview
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Brief Summary
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Oral lichen planus (OLP) is a chronic inflammatory mucocutaneous disease characterized by outbreaks or flares. It affects 0.2-1.9% of the population. Although the etiology is unknown, the pathogenesis of OLP is known to involve an immune disorder, with epithelial damage caused by cytotoxic CD8 + lymphocytes. Clinically, the disease is characterized by different types of lesions - papular, reticular and in the form of plaques - that can alternate with erosive and/or ulcerative areas. A variety of treatments have been proposed for OLP: topical or systemic corticosteroids, cyclosporine, retinoids, azathioprine, tacrolimus, pimecrolimus, photochemotherapy and surgery. Patients with symptomatic OLP often require intensive therapy to reduce the signs and symptoms. The disease can produce considerable morbidity and alter patient quality of life, particularly in the presence of ulcerative lesions. There is no fully resolutive and effective treatment - the management strategy focusing on the use of drugs that counter tissue inflammation and the underlying immunological mechanisms. The main inconvenience of these treatments is represented by the side effects they usually produce.

Detailed Description
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The purpose of this study was to evaluate that if Chamaemelum Nobile a can be used in the treatment of oral lichen planus. This could be useful as Chamaemelum Nobile 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.

Official Title
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Chamaemelum Nobile 2% Versus Placebo Topic Gel to Treatment Oral LichenPlanus

Conditions
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Oral Lichen Planus

Intervention / Treatment
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* Other: Chamaemelum nobile 2%
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients clinically & histopathologically diagnosed to be suffering from oral lichen planus. Patients who had symptoms i.e. pain and/or burning sensation secondary to oral lichen planus. Patients not on any treatment for the same. In case they were, then such treatment was stopped and a washout period of two weeks was given. Exclusion Criteria: Patients suffering from any systemic disease/s like Patients with any other mucosal disease or any other skin disease which may be associated with oral lesions. Patients on any drug therapy which may cause lichen planus like lesions. Patients with findings of any physical or mental abnormality, which would interfere with or be affected by the study procedure. Patients with a known allergy or contraindication to study medications

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Chamaemelum Nobile<br>Experimental Chamaemelum Nobile 2% gel During the 6-week double-blind phase, all patients will be randomly assigned to receive Chamaemelum Nobile 2% gel twice daily with occlusion on the affected are | Other: Chamaemelum nobile 2%<br>* Experimental Chamaemelum Nobile 2% gel Active During the 6-week double-blind phase, all patients will be randomly assigned to receive Chamaemelum Nobile 2% gel Active or its vehicle twice daily with occlusion on the affected are<br>|
| Placebo Comparator: Placebo<br>During the 6-week double-blind phase, all patients will be randomly assigned to receive vehicle ( placebo)twice daily with occlusion on the affected are | Other: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief from signs & symptoms of disease (Visual Analog Scale and change in size of target lesion) | The primary study end-point was the Visual Analog Scale (VAS) score for pain change in the size of the target erosion, erythema at the start and after 6week | 6 week |