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Clinical and Biochemical Assessment of the Effect of Topical Use of Coenzyme Q10 Versus Topical Corticosteroid in Management of Symptomatic Oral Lichen Planus: Randomized Controlled Clinical Trial

Primary Purpose

Oral Lichen Planus

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Co-Enzyme Q10 mucoadhesive tablets
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Lichen Planus focused on measuring co enzymeQ10 - Antioxidant- Corticosteroids

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients free from any systemic disease according to the detailed questionnaire of the modified Cornell Medical Index 34.
  2. Patients not receiving any medication either topical or systemic that could cause lichenoid reaction during the 3 months before the study.
  3. Patients diagnosed by a dermatologist and oral medicine specialist as suffering from OLP.
  4. Patients clinically and histopathologically diagnosed as suffering from OLP according to World Health Organization's (WHO's) clinic-pathological diagnostic criteria for LP35.
  5. Patients who agree for the biopsy in undiagnosed cases.
  6. Patients who are willing to participate in this study (will give informed consent) and have the ability to complete the study.

    • Exclusion criteria:

(1) Patients taking systemic drugs such as systemic steroid, other immunosuppressive therapy for at least 8 weeks prior to the study.

(2) Patients treated with any oral topical medications for at least four weeks prior to the study.

(3) Patients with suspected restoration-related reaction. (4) Pregnant and lactating mothers.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    topical Q10 mucoadhesive tablets

    topical corticosteroid

    Arm Description

    will receive topical co enzyme q10 in the form of mucoadhesive tablets 3 times daily for 3months.

    will receive topical corticosteroid (kenacort A Orabase: triamcinolone acetonide 0.1%5gram adhesive paste - dermapharm), 4 times daily for 3months.

    Outcomes

    Primary Outcome Measures

    pain score
    visual analogue scale scoring system
    clinical size of lesion
    Thongprasom score system

    Secondary Outcome Measures

    Salivary level of Malondialdehyde
    detect by ELISA

    Full Information

    First Posted
    September 13, 2019
    Last Updated
    September 13, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04091698
    Brief Title
    Clinical and Biochemical Assessment of the Effect of Topical Use of Coenzyme Q10 Versus Topical Corticosteroid in Management of Symptomatic Oral Lichen Planus: Randomized Controlled Clinical Trial
    Official Title
    11 El-Saraya St. - Manial - Cairo
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2019 (Anticipated)
    Primary Completion Date
    October 2021 (Anticipated)
    Study Completion Date
    November 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of the present investigation is to assess the clinical therapeutic effect of topical use of Coenzyme Q10 versus topical corticosteroid in management of symptomatic oral lichen planus and determine whether the effect, if any, was due to its antioxidant activity.
    Detailed Description
    Oral lichen planus (OLP) is a relatively common chronic inflammatory mucocutaneous autoimmune disease that primarily affects the skin and mucosal surfaces including the oral cavity with a variety of clinical manifestations including reticular, papular, hyperkeratotic, atrophic, erosive, and bullous forms 1,2. The erosive, atrophic, and bullous type lesions are usually accompanied with pain or burning sensation that affects the patient's quality of life3. Intraorally, the buccal mucosa, dorsum of the tongue and the gingiva are commonly affected 4 .OLP has most often been reported in middle aged patients3. Women account for 60% to 75% of patients with OLP 5. OLP is estimated to affect1% to 2.0% of the general population. Around 40% of lesions occur on both oral and cutaneous surfaces, 35% occurs on cutaneous surfaces alone, and 25% occur on oral mucosa alone 6,7. Several predisposing factors might be involved in the pathogenesis of OLP. Earlier studies have implicated stress, anxiety and depression as possible factors. Familial cases of OLP have been reported and the role of genetic predisposition was considered8. The exact etiology of OLP is still unknown, but cell-mediated immune dysfunction is implicated in the complex etio-pathogenesis of this disease. Large amounts of cytokines that are released by affected keratinocytes and the associated inflammatory elements play a key role in the selective recruitment of cytotoxic CD8+ T cells trigger apoptosis of the basal cells of the oral epithelium. T-cell dominated infiltrate in the sub epithelial region, which characterizes OLP, induces further release of cytokines9. Cytokines may be produced by nearly every cell, but mostly act locally on cell receptors and have high potency10. Their production gives rise to an inflammatory cascade. One of the most important elements in this cascade is overexpression of tumor necrosis factor-alpha (TNF- α). TNF- α causes tissue destruction and overproduction of other cytokines, especially interleukin (IL)-6 which, in turn, leads to further inflammation and tissue degradation 11. Production of cytokines can in turn stimulate production of Reactive Oxygen Species (ROS) and cause oxidative damage to the tissues 12 . Malondialdehyde (MDA), as the lipid peroxidation marker, increases in an oxidative stress-dependent situation 13. Actually, higher levels of MDA were reported in serum and saliva of patients affected by OLP14-17. A variety of treatments have been proposed for OLP: topical or systemic corticosteroids, cyclosporine, retinoids, azathioprine, tacrolimus, pimecrolimus, photo chemotherapy, and surgery 18. Systemic and topical corticosteroids are probably the most effective treatment modality for patients with diffuse erosive OLP or multisite disease 19 .Despite the therapeutic effects of corticosteroids, they have significant morbidity and disturbing adverse effects such as fungal infections and adrenal suppression. Moreover, steroid use is contraindicated in patients who are breastfeeding, and have to be used with caution in patients with herpetic infections, glaucoma, HIV infection, tuberculosis, diabetes mellitus, candidiasis, and hypertension, as well as in pregnant women, resulting in a continuing search for novel therapies 20. Coenzyme Q10 (CoQ10) or ubiquinone is a lipid-soluble vitamin-like antioxidant naturally found in the diet and can also be synthesized endogenously by all cells of our body. It is one of the key components in ATP production in ETC. CoQ10 protects membranes against oxidation, and regenerates vitamins E and C and enzymatic antioxidant systems, and modulates prostaglandin metabolism 21, 22. The maximal antioxidative power of the CoQ10 coenzyme is credited to its electron-donating properties that neutralize free radicals 23, and its ability to replenish other valuable endogenous antioxidants 24. CoQ10 is located in the membranes in close proximity to the unsaturated lipid chains to act as a primary scavenger of free radicals and prevent lipid peroxidation 25.. Any certain condition that leads to increased levels of ROS (either by overproduction or impaired removal) or reduced function of antioxidants is called "oxidative stress". ROS may be toxic to cells via inactive enzymes, denaturizing proteins, DNA destruction, and lipid peroxidation. These events lead to damaged cell membrane, increased reactive aldehyde materials, and impaired cell function. The level of ROS and lipid peroxidation may be related to OLP 26,27. This suggests that oxidative stress is a major trigger for OLP, and the level of antioxidants is a potential determinant of susceptibility to be affected by OLP 28, 29. In addition, studies have shown that CoQ10 also exerts anti-inflammatory properties via IL-1, TNF-α, and NFκB1-dependent gene expression, thus enhancing clearance of inflammation within the lesion to promote tissue regeneration and wound healing30. Papucci et al. 31 demonstrated that treatment with CoQ10 lowered the number of apoptotic keratocytes in response to excimer laser irradiation to a much higher extent than other free radical scavengers. Moreover, supplemental CoQ10 has good safety record; no adverse effects have been reported with daily dosage ranging from 600 to 1200mg

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oral Lichen Planus
    Keywords
    co enzymeQ10 - Antioxidant- Corticosteroids

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Model Description
    two parallel group one take Q10 mucoadhesive tablets and other take topical corticosteroid for 3 months follow up measuring pain ,clinical size of lesion and salivary level of Malondialdehyde as oxidative biomarker
    Masking
    Outcomes Assessor
    Masking Description
    Double-blinded trial, outcome assessors and statistician
    Allocation
    Randomized
    Enrollment
    34 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    topical Q10 mucoadhesive tablets
    Arm Type
    Active Comparator
    Arm Description
    will receive topical co enzyme q10 in the form of mucoadhesive tablets 3 times daily for 3months.
    Arm Title
    topical corticosteroid
    Arm Type
    Placebo Comparator
    Arm Description
    will receive topical corticosteroid (kenacort A Orabase: triamcinolone acetonide 0.1%5gram adhesive paste - dermapharm), 4 times daily for 3months.
    Intervention Type
    Drug
    Intervention Name(s)
    Co-Enzyme Q10 mucoadhesive tablets
    Other Intervention Name(s)
    Q10 mucoadhesive tablets -ubiquinol
    Intervention Description
    will receive topical co enzyme q10 in the form of mucoadhesive tablets 3 times daily for 3months.
    Primary Outcome Measure Information:
    Title
    pain score
    Description
    visual analogue scale scoring system
    Time Frame
    3months
    Title
    clinical size of lesion
    Description
    Thongprasom score system
    Time Frame
    3months
    Secondary Outcome Measure Information:
    Title
    Salivary level of Malondialdehyde
    Description
    detect by ELISA
    Time Frame
    3months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients free from any systemic disease according to the detailed questionnaire of the modified Cornell Medical Index 34. Patients not receiving any medication either topical or systemic that could cause lichenoid reaction during the 3 months before the study. Patients diagnosed by a dermatologist and oral medicine specialist as suffering from OLP. Patients clinically and histopathologically diagnosed as suffering from OLP according to World Health Organization's (WHO's) clinic-pathological diagnostic criteria for LP35. Patients who agree for the biopsy in undiagnosed cases. Patients who are willing to participate in this study (will give informed consent) and have the ability to complete the study. Exclusion criteria: (1) Patients taking systemic drugs such as systemic steroid, other immunosuppressive therapy for at least 8 weeks prior to the study. (2) Patients treated with any oral topical medications for at least four weeks prior to the study. (3) Patients with suspected restoration-related reaction. (4) Pregnant and lactating mothers.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    mostafa abdelsamie, demonstrator
    Phone
    01004165905
    Email
    mostafa.abdelsamie@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    fatheya zahran, professor
    Email
    fatheya.zahran@dentistry.cu.edu.eg

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22203938
    Citation
    Scrobota I, Mocan T, Catoi C, Bolfa P, Muresan A, Baciut G. Histopathological aspects and local implications of oxidative stress in patients with oral lichen planus. Rom J Morphol Embryol. 2011;52(4):1305-9.
    Results Reference
    background
    PubMed Identifier
    11134848
    Citation
    Sugerman PB, Savage NW, Zhou X, Walsh LJ, Bigby M. Oral lichen planus. Clin Dermatol. 2000 Sep-Oct;18(5):533-9. doi: 10.1016/s0738-081x(00)00142-5. No abstract available.
    Results Reference
    background
    PubMed Identifier
    17634721
    Citation
    Ismail SB, Kumar SK, Zain RB. Oral lichen planus and lichenoid reactions: etiopathogenesis, diagnosis, management and malignant transformation. J Oral Sci. 2007 Jun;49(2):89-106. doi: 10.2334/josnusd.49.89.
    Results Reference
    background
    PubMed Identifier
    17482886
    Citation
    Bhagavan HN, Chopra RK. Plasma coenzyme Q10 response to oral ingestion of coenzyme Q10 formulations. Mitochondrion. 2007 Jun;7 Suppl:S78-88. doi: 10.1016/j.mito.2007.03.003. Epub 2007 Mar 27.
    Results Reference
    background
    PubMed Identifier
    16850138
    Citation
    Yang LL, Liu XQ, Liu W, Cheng B, Li MT. Comparative analysis of whole saliva proteomes for the screening of biomarkers for oral lichen planus. Inflamm Res. 2006 Oct;55(10):405-7. doi: 10.1007/s00011-006-5145-8.
    Results Reference
    background

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    Clinical and Biochemical Assessment of the Effect of Topical Use of Coenzyme Q10 Versus Topical Corticosteroid in Management of Symptomatic Oral Lichen Planus: Randomized Controlled Clinical Trial

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