Oral Lichen PlanusNCT06533033
Melatonin Epigenetic Potential in Preventing Malignant Transformation of Oral Lichen Planus
A study testing Rapid Release Capsules Melatoni and Triamcinolone Acetonide ointment, Kenacort-A orabase in people with Oral Lichen Planus, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Background: Oral Lichen planus (OLP) is one of the most common oral diseases that has an unneglectable rate of malignant transformation. Recently malignant transformation has been definitively linked to epigenetic changes. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Rapid Release Capsules Melatoni and Triamcinolone Acetonide ointment, Kenacort-A orabase
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Aug 2024
- Phase
- Interventional
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients clinically and histopathologically diagnosed to be suffering from OLP in the following forms has been reported in the literature to have the highest potentiality for malignant transformation (plaque-type lichen , Erosive lichen planus, ulcerative lichen planus), with or without histopathological dysplasia.
- Patients who have symptoms (i.e. pain and burning sensation) secondary to OLP.
Who cannot join
- Patients suspected to have lichenoid drug reaction or lichenoid contact allergy.
- Patients suffering from systemic diseases (such as diabetes, cardiovascular or liver disorders, renal dysfunction).
- Patients with findings of any physical or mental abnormality that would interfere with or be affected by the study procedure.
- Patients who have adverse habits of chewing tobacco and smoking.
- Pregnant and lactating women.
- Patients under treatment with corticosteroids and immunosuppressants.
- Patients exhibiting any skin manifestations of OLP
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria
About this study
Official title: Melatonin Epigenetic Potential in Preventing Malignant Transformation of Oral Lichen Planus Epigenetic Randomized Clinical Trial
Background: Oral Lichen planus (OLP) is one of the most common oral diseases that has an unneglectable rate of malignant transformation. Recently malignant transformation has been definitively linked to epigenetic changes. One of those most common changes is DNA hypermethylation that causes tumor suppressor genes to downtranslate and thus carcinogenesis begins. ZNF582 gene hypermethylation is emerging as an exclusive biomarker to differentiate between normal and dysplastic changes that occur over the epithelium. Aim: To evaluate the Melatonin epigenetic potential in preventing malignant transformation of OLP. Material and methods: an epigenetic randomized clinical study will be conducted on 50 patients suffering from OLP, recruited from the outpatient clinic of Oral medicine department, Alexandria Faculty of Dentistry, Egypt. Patients will be assigned to either Control group who will receive topical corticosteroids and antifungal treatment, or test group who will receive melatonin supplement in addition to conventional treatment. All patients will be genetically evaluated for the level of DNA hypermethylation 8 weeks after treatment, and clinically evaluated for disease severity and pain, by Elsabagh scoring system 4. 8, and 12 weeks after treatment.
- Conditions
- Oral Lichen Planus
- Being tested
- Rapid Release Capsules Melatoni, Triamcinolone Acetonide ointment, Kenacort-A orabase
- 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.
Rapid Release Capsules MelatoniDrug
Twenty-five will be given melatonin therapy in combination with the conventional treatment.
2 tablets,30 minutes before sleeping once daily for 8 weeks.
Triamcinolone Acetonide ointment, Kenacort-A orabaseDrug
Twenty-five will be given topical corticosteroid applied twice to three times daily.
Topical antifungal will be applied three to four times daily. This conventional treatment will be given to the patients for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| melatonin therapy | Experimental | Not described Receives: Drug: Rapid Release Capsules Melatoni |
| topical corticosteroid a | Active comparator | Not described Receives: Drug: Triamcinolone Acetonide ointment, Kenacort-A orabase |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in DNA methylation level of tumor suppressor gene (ZNF852)
The ZNF582 gene sequence will be obtained from the University of California, Santa Cruz, Genomics Institute.
website (http://genome.ucsc.edu/), and the methylation-specific PCR primers for ZNF582 will be acquired from MethPrimer (http://www.urogene.org/cgibin/ methprimer/methprimer.cgi).
Measured: up to 8 weeks
Change in oral lesions
Oral lesions will be evaluated clinically after treatment using Elsabagh et al score.
Objective mucosal lesion nature (no lesion= 0, White keratotic lesion =1, Atrophy/Erosion intermixed or not with White lesion = 2, Ulceration intermixed or not with White lesion = 3)
Measured: Up to 12 weeks
Change in pain scores
Subjective pain score (no pain =0, mild pain=1, moderate pain=2, severe pain=3)
Measured: Up to 12 weeks
Change in number of affected surfaces in oral cavity
Number of surfaces affected in the oral cavity other than the gingiva (only one surface affected or buccal mucosae bilaterally =0, more than one surface affected or more than both buccal mucosae=1)
Measured: Up to 12 weeks
Change in gingival involvement
Gingival involvement as desquamative gingivitis (no gingival involvement = 0, narrow band (1mm) of gingival involvement or wide band in less than 6 teeth involved =1, wide band (>1mm) of gingival involvement in more than 6 teeth involved = 2)
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Jan 2024
- Primary completion31 Jul 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533033
- Sponsor's protocol ID
- Melatonin_2023
- Status last verified
- Jul 2024
- First submitted
- 25 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin Epigenetic Potential in Preventing Malignant Transformation of Oral Lichen Planus Epigenetic Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06533033
- Acronym / sponsor ID
- Melatonin_2023
- Conditions
- Oral Lichen Planus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 1 Aug 2024 (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.
Background: Oral Lichen planus (OLP) is one of the most common oral diseases that has an unneglectable rate of malignant transformation. Recently malignant transformation has been definitively linked to epigenetic changes. One of those most common changes is DNA hypermethylation that causes tumor suppressor genes to downtranslate and thus carcinogenesis begins. ZNF582 gene hypermethylation is emerging as an exclusive biomarker to differentiate between normal and dysplastic changes that occur over the epithelium. Aim: To evaluate the Melatonin epigenetic potential in preventing malignant transformation of OLP. Material and methods: an epigenetic randomized clinical study will be conducted on 50 patients suffering from OLP, recruited from the outpatient clinic of Oral medicine department, Alexandria Faculty of Dentistry, Egypt. Patients will be assigned to either Control group who will receive topical corticosteroids and antifungal treatment, or test group who will receive melatonin supplement in addition to conventional treatment. All patients will be genetically evaluated for the level of DNA hypermethylation 8 weeks after treatment, and clinically evaluated for disease severity and pain, by Elsabagh scoring system 4. 8, and 12 weeks after treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| melatonin therapy | Experimental | Drug: Rapid Release Capsules Melatoni |
| topical corticosteroid a | Active comparator | Drug: Triamcinolone Acetonide ointment, Kenacort-A orabase |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients clinically and histopathologically diagnosed to be suffering from OLP in the following forms has been reported in the literature to have the highest potentiality for malignant transformation (plaque-type lichen , Erosive lichen planus, ulcerative lichen planus), with or without histopathological dysplasia.
- Patients who have symptoms (i.e. pain and burning sensation) secondary to OLP.
Key exclusion criteria (7 listed)
- Patients suspected to have lichenoid drug reaction or lichenoid contact allergy.
- Patients suffering from systemic diseases (such as diabetes, cardiovascular or liver disorders, renal dysfunction).
- Patients with findings of any physical or mental abnormality that would interfere with or be affected by the study procedure.
- Patients who have adverse habits of chewing tobacco and smoking.
- Pregnant and lactating women.
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 |
|---|---|---|
| Rapid Release Capsules MelatoniTwenty-five will be given melatonin therapy in combination with the conventional treatment. 2 tablets,30 minutes before sleeping once daily for 8 weeks. | Drug | melatonin therapy |
| Triamcinolone Acetonide ointment, Kenacort-A orabaseTwenty-five will be given topical corticosteroid applied twice to three times daily. Topical antifungal will be applied three to four times daily. This conventional treatment will be given to the patients for 8 weeks | Drug | topical corticosteroid a |
Primary outcome
change in DNA methylation level of tumor suppressor gene (ZNF852)
Time frame: up to 8 weeks
The ZNF582 gene sequence will be obtained from the University of California, Santa Cruz, Genomics Institute. website (http://genome.ucsc.edu/), and the methylation-specific PCR primers for ZNF582 will be acquired from MethPrimer (http://www.urogene.org/cgibin/ methprimer/methprimer.cgi).
Change in oral lesions
Time frame: Up to 12 weeks
Oral lesions will be evaluated clinically after treatment using Elsabagh et al score. Objective mucosal lesion nature (no lesion= 0, White keratotic lesion =1, Atrophy/Erosion intermixed or not with White lesion = 2, Ulceration intermixed or not with White lesion = 3)
Change in pain scores
Time frame: Up to 12 weeks
Subjective pain score (no pain =0, mild pain=1, moderate pain=2, severe pain=3)
Change in number of affected surfaces in oral cavity
Time frame: Up to 12 weeks
Number of surfaces affected in the oral cavity other than the gingiva (only one surface affected or buccal mucosae bilaterally =0, more than one surface affected or more than both buccal mucosae=1)
Change in gingival involvement
Time frame: Up to 12 weeks
Gingival involvement as desquamative gingivitis (no gingival involvement = 0, narrow band (1mm) of gingival involvement or wide band in less than 6 teeth involved =1, wide band (>1mm) of gingival involvement in more than 6 teeth involved = 2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
Related trials for Oral Lichen Planus
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Not yet recruiting
Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
Oral Lichen Planus
Not yet recruiting
Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
Degree of Adherence of Symptomatic OLP Patients to Their Medications
Active, not recruitingPhase 4
Low Level Laser Therapy With Injectable Platelet Rich Fibrin in Management of Oral Lichen Planus
Oral Lichen Planus
Active, not recruiting
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Erythroplakia, Fanconi Anemia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid Release Capsules Melatoni and Triamcinolone Acetonide ointment, Kenacort-A orabase in people with Oral Lichen Planus, run by Hams Hamed Abdelrahman at 1 site in Egypt.
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 2 inclusion and 7 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 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in DNA methylation level of tumor suppressor gene (ZNF852) (time frame: up to 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2024.