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

Phase 3

Completed

• Conditions: Oral Lichen Planus
• Interventions: Other: Chamaemelum nobile 2%; Other: placebo

• Registration Number: NCT02421770
• Lead Sponsor: Universidad de Murcia

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-01
• Study First Submitted: 2015-04-08
• Study First Submitted QC: 2015-04-20
• Study First Posted: 2015-04-21
• Study Completion: 2015-07
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Chamaemelum Nobile	Chamaemelum nobile 2%	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
Placebo	placebo	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

Primary Outcome Measures

Name	Time	Method
Relief from signs & symptoms of disease (Visual Analog Scale and change in size of target lesion)	6 week	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

Trial Locations

Locations (1)

Pia Lopez Jornet; 🇪🇸 Murcia, Spain