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

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

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.

Study Overview

• Status: Completed
• Conditions: Oral Lichen Planus
• Intervention / Treatment: Other: placebo; Other: Chamaemelum nobile 2%

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30008
    • Pia Lopez Jornet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Other: 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
PLACEBO_COMPARATOR: 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	Other: placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad de Murcia
• Investigators: Principal Investigator: Pia Lopez Jornet, MD,DDS,PhD, Universidad de Murcia

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ACTUAL): January 1, 2015
• Study Completion (ACTUAL): July 1, 2015

Study Registration Dates

• First Submitted: April 8, 2015
• First Submitted That Met QC Criteria: April 20, 2015
• First Posted (ESTIMATE): April 21, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): December 2, 2015
• Last Update Submitted That Met QC Criteria: November 30, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Stomatognathic Diseases; Mouth Diseases; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Lichen Planus, Oral; Lichen Planus
• Other Study ID Numbers: UMurcia