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

NCT ID: NCT02421770

Last Updated: 2015-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-07-31

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.

Conditions

Oral Lichen Planus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental Chamaemelum Nobile

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

Group Type: EXPERIMENTAL

Chamaemelum nobile 2%

Intervention Type: OTHER

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

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Interventions

Chamaemelum nobile 2%

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

Intervention Type: OTHER

placebo

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Murcia

OTHER

Sponsor Role: lead

Responsible Party

Pia Lopez Jornet

MD, DDS, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pia Lopez Jornet, MD,DDS,PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Murcia

Locations

Pia Lopez Jornet

Murcia, Murcia, Spain

Countries

Spain

References

Varoni EM, Lodi G, Sardella A, Carrassi A, Iriti M. Plant polyphenols and oral health: old phytochemicals for new fields. Curr Med Chem. 2012;19(11):1706-20. doi: 10.2174/092986712799945012.

Reference Type: BACKGROUND

PMID: 22376030 (View on PubMed)

Petti S, Scully C. Polyphenols, oral health and disease: A review. J Dent. 2009 Jun;37(6):413-23. doi: 10.1016/j.jdent.2009.02.003. Epub 2009 Mar 19.

Reference Type: BACKGROUND

PMID: 19303186 (View on PubMed)

Thongprasom K, Prapinjumrune C, Carrozzo M. Novel therapies for oral lichen planus. J Oral Pathol Med. 2013 Nov;42(10):721-7. doi: 10.1111/jop.12083. Epub 2013 May 13.

Reference Type: RESULT

PMID: 23668304 (View on PubMed)

Lodi G, Carrozzo M, Furness S, Thongprasom K. Interventions for treating oral lichen planus: a systematic review. Br J Dermatol. 2012 May;166(5):938-47. doi: 10.1111/j.1365-2133.2012.10821.x. Epub 2012 Mar 27.

Reference Type: RESULT

PMID: 22242640 (View on PubMed)

Other Identifiers

UMurcia

Identifier Type: -

Identifier Source: org_study_id