Clinical trial NCT02421770: Chamaemelum Nobile 2% Versus Placebo Topic Gel to Treat Oral Lichen Planus
Official title: Chamaemelum Nobile 2% Versus Placebo Topic Gel to Treatment Oral LichenPlanus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Oral Lichen Planus
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2015-04-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Relief from signs & symptoms of disease (Visual Analog Scale and change in size of target lesion)
timeFrame: 6 week
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Pia Lopez Jornet
Study officials:
affiliation: Universidad de Murcia
name: Pia Lopez Jornet, MD,DDS,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.