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

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

Sponsors

Lead Sponsor: Universidad de Murcia

Source 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.

Overall Status Completed
Start Date January 2014
Completion Date July 2015
Primary Completion Date January 2015
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Relief from signs & symptoms of disease (Visual Analog Scale and change in size of target lesion) 6 week
Enrollment 30
Condition
Intervention

Intervention Type: Other

Intervention Name: Chamaemelum nobile 2%

Description: 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

Arm Group Label: Experimental Chamaemelum Nobile

Intervention Type: Other

Intervention Name: placebo

Arm Group Label: Placebo

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Pia Lopez Jornet, MD,DDS,PhD Principal Investigator Universidad de Murcia
Location
Facility: Pia Lopez Jornet
Location Countries

Spain

Verification Date

November 2015

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Universidad de Murcia

Investigator Full Name: Pia Lopez Jornet

Investigator Title: MD, DDS, PhD

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Experimental Chamaemelum Nobile

Type: Experimental

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

Label: Placebo

Type: Placebo Comparator

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

Acronym lichenPlanus
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov