Oral Lichen Planus Clinical Trial
Official title:
11 El-Saraya St. - Manial - Cairo
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.
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
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