Chamaemelum Nobile 2% Versus Placebo Topic Gel to Treat Oral Lichen Planus (lichenPlanus)
Primary Purpose
Oral Lichen Planus
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Chamaemelum nobile 2%
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Oral Lichen Planus
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Pia Lopez Jornet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental Chamaemelum Nobile
Placebo
Arm 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
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02421770
Brief Title
Chamaemelum Nobile 2% Versus Placebo Topic Gel to Treat Oral Lichen Planus
Acronym
lichenPlanus
Official Title
Chamaemelum Nobile 2% Versus Placebo Topic Gel to Treatment Oral LichenPlanus
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Murcia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Lichen Planus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Chamaemelum Nobile
Arm Type
Experimental
Arm 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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Other
Intervention Name(s)
Chamaemelum nobile 2%
Intervention 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
Intervention Type
Other
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Relief from signs & symptoms of disease (Visual Analog Scale and change in size of target lesion)
Description
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
Time Frame
6 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pia Lopez Jornet, MD,DDS,PhD
Organizational Affiliation
Universidad de Murcia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pia Lopez Jornet
City
Murcia
ZIP/Postal Code
30008
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
22376030
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.
Results Reference
background
PubMed Identifier
19303186
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.
Results Reference
background
PubMed Identifier
23668304
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.
Results Reference
result
PubMed Identifier
22242640
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.
Results Reference
result
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Chamaemelum Nobile 2% Versus Placebo Topic Gel to Treat Oral Lichen Planus
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