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

Universidad de Murcia

Status and phase: Completed; Phase 3

Conditions: Oral Lichen Planus

Treatments: Other: Chamaemelum nobile 2%; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02421770

UMurcia

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients clinically & histopathologically diagnosed to be suffering from oral lichen planus.
2. Patients who had symptoms i.e. pain and/or burning sensation secondary to oral lichen planus.
3. 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

1. Patients suffering from any systemic disease/s like
2. Patients with any other mucosal disease or any other skin disease which may be associated with oral lesions.
3. Patients on any drug therapy which may cause lichen planus like lesions.
4. Patients with findings of any physical or mental abnormality, which would interfere with or be affected by the study procedure.
5. Patients with a known allergy or contraindication to study medications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Experimental Chamaemelum Nobile

Experimental group

Description:

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

Treatment:

Other: Chamaemelum nobile 2%

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: placebo