Oral Lichen PlanusPhase 1NCT04091698
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
A Phase 1 study testing Co-Enzyme Q10 mucoadhesive tablets in people with Oral Lichen Planus, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Co-Enzyme Q10 mucoadhesive tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients taking systemic drugs such as systemic steroid, other immunosuppressive therapy for at least 8 weeks prior to the study.
- Patients treated with any oral topical medications for at least four weeks prior to the study.
- Patients with suspected restoration-related reaction. (4) Pregnant and lactating mothers.
Trial locations and contacts
No sites are listed yet.
fatheya zahran, professor contact
About this study
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.
Read the 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
- Conditions
- Oral Lichen Planus
- Being tested
- Co-Enzyme Q10 mucoadhesive tablets
- Keywords
- co enzymeQ10 - Antioxidant- Corticosteroids
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-Enzyme Q10 mucoadhesive tabletsDrug
Also called Q10 mucoadhesive tablets -ubiquinol
will receive topical co enzyme q10 in the form of mucoadhesive tablets 3 times daily for 3months.
| Study group | Role | What they receive |
|---|---|---|
| topical Q10 mucoadhesive tablets | Active comparator | will receive topical co enzyme q10 in the form of mucoadhesive tablets 3 times daily for 3months. Receives: Drug: Co-Enzyme Q10 mucoadhesive tablets |
| topical corticosteroid | Placebo comparator | will receive topical corticosteroid (kenacort A Orabase: triamcinolone acetonide 0.1%5gram adhesive paste - dermapharm), 4 times daily for 3months. Receives: Drug: Co-Enzyme Q10 mucoadhesive tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
visual analogue scale scoring system
Measured: 3months
clinical size of lesion
Thongprasom score system
Measured: 3months
Secondary outcomes (1)
Salivary level of Malondialdehyde
detect by ELISA
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Abdelsamie Bakry Nafie, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091698
- Sponsor's protocol ID
- Q10 in oral lichen planus
- Status last verified
- Sep 2019
- First submitted
- 13 Sep 2019
- Last updated
- 17 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22203938Sugerman 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.
PubMed 11134848Ismail 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.
PubMed 17634721Bhagavan 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.
PubMed 17482886Yang 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.
PubMed 16850138Abdelsamie M, Zahran F, Hussine AA, Shaker O, Al-Mahallawi AM. 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. BMC Oral Health. 2023 Jul 21;23(1):506. doi: 10.1186/s12903-023-03206-5.
PubMed 37480004
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 11 El-Saraya St. - Manial - Cairo
- ClinicalTrials.gov ID
- NCT04091698
- Acronym / sponsor ID
- Q10 in oral lichen planus
- Conditions
- Oral Lichen Planus
- Keywords
- co enzymeQ10 - Antioxidant- Corticosteroids
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 17 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| topical Q10 mucoadhesive tablets | Active comparator | Drug: Co-Enzyme Q10 mucoadhesive tabletswill receive topical co enzyme q10 in the form of mucoadhesive tablets 3 times daily for 3months. |
| topical corticosteroid | Placebo comparator | Drug: Co-Enzyme Q10 mucoadhesive tabletswill receive topical corticosteroid (kenacort A Orabase: triamcinolone acetonide 0.1%5gram adhesive paste - dermapharm), 4 times daily for 3months. |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients taking systemic drugs such as systemic steroid, other immunosuppressive therapy for at least 8 weeks prior to the study.
- Patients treated with any oral topical medications for at least four weeks prior to the study.
- Patients with suspected restoration-related reaction. (4) Pregnant and lactating mothers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Co-Enzyme Q10 mucoadhesive tabletsAlso: Q10 mucoadhesive tablets -ubiquinolwill receive topical co enzyme q10 in the form of mucoadhesive tablets 3 times daily for 3months. | Drug | topical Q10 mucoadhesive tablets, topical corticosteroid |
Primary outcome
pain score
Time frame: 3months
visual analogue scale scoring system
clinical size of lesion
Time frame: 3months
Thongprasom score system
1 secondary outcome
Salivary level of Malondialdehyde
Time frame: 3months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Background: PubMed 22203938Scrobota 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.
- Background: PubMed 11134848Sugerman 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.
- Background: PubMed 17634721Ismail 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.
- Background: PubMed 17482886Bhagavan 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.
- Background: PubMed 16850138Yang 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.
- Derived from this study: PubMed 37480004Abdelsamie M, Zahran F, Hussine AA, Shaker O, Al-Mahallawi AM. 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. BMC Oral Health. 2023 Jul 21;23(1):506. doi: 10.1186/s12903-023-03206-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
fatheya zahran, professor contact
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Co-Enzyme Q10 mucoadhesive tablets in people with Oral Lichen Planus, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mostafa abdelsamie, demonstrator (01004165905, mostafa.abdelsamie@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score (time frame: 3months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04091698, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.