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

NCT02421770 | Completed Phase 3 DMC

• 1 other identifier: UMurcia
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Lichen Planus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Experimental Chamaemelum Nobile

EXPERIMENTAL

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%

Placebo

PLACEBO COMPARATOR

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

Interventions

Chamaemelum nobile 2% 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

Experimental Chamaemelum Nobile

placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients clinically \& histopathologically diagnosed to be suffering from oral lichen planus.
• Patients who had symptoms i.e. pain and/or burning sensation secondary to oral lichen planus.
• 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.

You may not qualify if:

• Patients suffering from any systemic disease/s like
• Patients with any other mucosal disease or any other skin disease which may be associated with oral lesions.
• Patients on any drug therapy which may cause lichen planus like lesions.
• Patients with findings of any physical or mental abnormality, which would interfere with or be affected by the study procedure.
• Patients with a known allergy or contraindication to study medications

Sponsors & Collaborators

• Universidad de Murcia: lead

Study Sites (1)

Pia Lopez Jornet

Murcia, Murcia, 30008, Spain

Location

Related Publications (4)

• 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.

  PMID: 22376030 BACKGROUND

• 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.

  PMID: 19303186 BACKGROUND

• 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.

  PMID: 23668304 RESULT

• 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.

  PMID: 22242640 RESULT

MeSH Terms

Conditions

Lichen Planus, Oral

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pia Lopez Jornet, MD,DDS,PhD

  Universidad de Murcia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DDS, PhD

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: April 21, 2015
• Study Start: January 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

ES (1)