Oral Lichen PlanusNCT06078579
Salivary and Serum Leptin Levels in Oral Lichen Planus Patients: A Case-control Study.
An observational study of Oral Lichen Planus and Leptin Levels, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to evaluate the levels of leptin in both saliva and serum samples of patients diagnosed with oral lichen. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Lichen Planus, Leptin Levels
- What is being tested?
- Leptin
- Type of treatment
- Pill or oral medicine
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2023to 30 Dec 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: OLP patients and healthy controls were selected will be selected from "out-patient clinic" of Oral Medicine, Periodontology and Oral Diagnosis Department ;Faculty of Dentistry, Cairo university and from "out-patient" of Boulak El Dakroor general hospital.
Who may be able to join
- Ages for both sexes fall between 30 and 70.
- Symptomatic OLP has been diagnosed clinically and verified histologically.
- Participants who sign a written consent form after being fully informed about the study.
Who cannot join
- Treatment with a systemic or locally administered systemic medication within the previous three months before the commencement of the research.
- Patients now taking or who have just stopped taking an NSAIDs (both steroidal and non steroidal) for pain or inflammation.
- Patients who have been diagnosed with a malignant tumor or tumors.
- Women who are expecting or nursing.
- Inmates, the mentally ill, the elderly, etc, all fall into this category.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Salivary and Serum Leptin Levels in Oral Lichen Planus Patients: A Case-Control Study.
This study aims to evaluate the levels of leptin in both saliva and serum samples of patients diagnosed with oral lichen.
Read the detailed description
Oral lichen planus is a frequently encountered chronic muco-cutaneous condition with a high prevalence rate. The condition can be classified as an autoimmune disorder.Although the exact cause of this condition is unknown, some potential risk factors should be taken into account, such as systemic disorders, psychogenic diseases, dental restorations, and certain medications.
The oral lesions exhibit a mostly bilateral pattern, often manifesting in the inner buccal mucosa. The condition can be classified into three distinct forms, namely the reticular form, atrophic form, and bullous-erosive form.
The condition is classified as a premalignant lesion due to its significant likelihood of undergoing malignant transformation. The disease is characterized by the presence of T-lymphocyte infiltration in the basal cell layer of the epithelium and the presence of cytoid bodies, which are distinct histopathologic markers.
Leptin, a hormone generated by adipocytes, is involved in immunological responses and contributes to the development of autoimmunity. The presence of dyslipidemia has been found to be associated with lipoprotein (LP) abnormalities. Consequently, this study was undertaken to assess the blood leptin levels and lipid profile in individuals with LP. Leptin, a polypeptide hormone, is produced and released by white adipose tissue.
Multiple research have substantiated an increase in leptin levels among persons exhibiting elevated body mass index (BMI) and a higher percentage of total body fat. Additionally, it is involved in the cellular immune response and facilitates the development of autoimmunity.
There is a proposition suggesting that leptin has a role in the promotion of cytokine generation and modulation of helper T cells, potentially implicating its involvement in the pathogenesis of psoriasis. The available information about leptin status in dermatological illnesses other than psoriasis is currently sparse. It is plausible that it may have a significant role in the pathogenesis of lichen planus.
However, there is a lack of literature regarding the levels of leptin in LP. There is an association between dyslipidemia and LP. Numerous investigations have consistently demonstrated notable deviations in lipid profile levels between individuals with LP and those in normal, healthy control cohorts. These findings have led researchers to posit a correlation between chronic inflammation and dyslipidemia, hence heightening the susceptibility to cardiovascular illnesses.
The potential impact of leptin on the progression of LP is being investigated. The objective of this study was to conduct a comparative analysis of blood leptin levels between individuals recently diagnosed with LP and a control group consisting of healthy individuals. Additionally, an assessment was conducted to examine the correlation between leptin levels, lipid profile, and the length of illness.
- Conditions
- Oral Lichen Planus, Leptin Levels
- Being tested
- Leptin
- Keywords
- salivary, Serum
- 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.
LeptinDiagnostic test
Assessment of salivary and serum leptin levels in oral lichen planus patients and healthy controls
| Study group | Role | What they receive |
|---|---|---|
| Oral lichen planus patients | Assessment of salivary and serum leptin levels Receives: Diagnostic Test: Leptin | |
| Healthy control group | Assessment of salivary and serum leptin levels Receives: Diagnostic Test: Leptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Leptin Level
Assessment of serum leptin levels in in oral lichen planus patients
Measured: Baseline
Secondary outcomes (1)
Salivary Leptin Levels
Assessment of salivary leptin levels in oral lichen planus patients
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start30 Dec 2023
- Primary completion30 Nov 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahaa Mahmoud Fawzy El Nomrosy, Cairo University
- Investigators
- Weam Ah Rashwan, PHD, Study director, Cairo UniversityOlfat Ga Shaker, PHD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078579
- Sponsor's protocol ID
- 20723
- Status last verified
- Mar 2025
- First submitted
- 27 Sep 2023
- Last updated
- 30 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aryanian Z, Shirzadian A, Hatami P, Dadras H. High Incidence of Metabolic Syndrome Components in Lichen Planus Patients: A Prospective Cross-Sectional Study. Int J Clin Pract. 2022 Jan 31;2022:7184678. doi: 10.1155/2022/7184678. eCollection 2022.
PubMed 35685585Matarese G, Moschos S, Mantzoros CS. Leptin in immunology. J Immunol. 2005 Mar 15;174(6):3137-42. doi: 10.4049/jimmunol.174.6.3137.
PubMed 15749839
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary and Serum Leptin Levels in Oral Lichen Planus Patients: A Case-Control Study.
- ClinicalTrials.gov ID
- NCT06078579
- Acronym / sponsor ID
- 20723
- Conditions
- Oral Lichen Planus, Leptin Levels
- Keywords
- salivary, Serum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Dec 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 12 Oct 2023 (actual)
- Results
- Posted 30 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the levels of leptin in both saliva and serum samples of patients diagnosed with oral lichen.
Detailed description
Oral lichen planus is a frequently encountered chronic muco-cutaneous condition with a high prevalence rate. The condition can be classified as an autoimmune disorder.Although the exact cause of this condition is unknown, some potential risk factors should be taken into account, such as systemic disorders, psychogenic diseases, dental restorations, and certain medications.
The oral lesions exhibit a mostly bilateral pattern, often manifesting in the inner buccal mucosa. The condition can be classified into three distinct forms, namely the reticular form, atrophic form, and bullous-erosive form.
The condition is classified as a premalignant lesion due to its significant likelihood of undergoing malignant transformation. The disease is characterized by the presence of T-lymphocyte infiltration in the basal cell layer of the epithelium and the presence of cytoid bodies, which are distinct histopathologic markers.
Leptin, a hormone generated by adipocytes, is involved in immunological responses and contributes to the development of autoimmunity. The presence of dyslipidemia has been found to be associated with lipoprotein (LP) abnormalities. Consequently, this study was undertaken to assess the blood leptin levels and lipid profile in individuals with LP. Leptin, a polypeptide hormone, is produced and released by white adipose tissue.
Multiple research have substantiated an increase in leptin levels among persons exhibiting elevated body mass index (BMI) and a higher percentage of total body fat. Additionally, it is involved in the cellular immune response and facilitates the development of autoimmunity.
There is a proposition suggesting that leptin has a role in the promotion of cytokine generation and modulation of helper T cells, potentially implicating its involvement in the pathogenesis of psoriasis. The available information about leptin status in dermatological illnesses other than psoriasis is currently sparse. It is plausible that it may have a significant role in the pathogenesis of lichen planus.
However, there is a lack of literature regarding the levels of leptin in LP. There is an association between dyslipidemia and LP. Numerous investigations have consistently demonstrated notable deviations in lipid profile levels between individuals with LP and those in normal, healthy control cohorts. These findings have led researchers to posit a correlation between chronic inflammation and dyslipidemia, hence heightening the susceptibility to cardiovascular illnesses.
The potential impact of leptin on the progression of LP is being investigated. The objective of this study was to conduct a comparative analysis of blood leptin levels between individuals recently diagnosed with LP and a control group consisting of healthy individuals. Additionally, an assessment was conducted to examine the correlation between leptin levels, lipid profile, and the length of illness.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral lichen planus patients | – | Diagnostic Test: LeptinAssessment of salivary and serum leptin levels |
| Healthy control group | – | Diagnostic Test: LeptinAssessment of salivary and serum leptin levels |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- OLP patients and healthy controls were selected will be selected from "out-patient clinic" of Oral Medicine, Periodontology and Oral Diagnosis Department ;Faculty of Dentistry, Cairo university and from "out-patient" of Boulak El Dakroor general hospital.
Key inclusion criteria (3 listed)
- Ages for both sexes fall between 30 and 70.
- Symptomatic OLP has been diagnosed clinically and verified histologically.
- Participants who sign a written consent form after being fully informed about the study.
Key exclusion criteria (5 listed)
- Treatment with a systemic or locally administered systemic medication within the previous three months before the commencement of the research.
- Patients now taking or who have just stopped taking an NSAIDs (both steroidal and non steroidal) for pain or inflammation.
- Patients who have been diagnosed with a malignant tumor or tumors.
- Women who are expecting or nursing.
- Inmates, the mentally ill, the elderly, etc, all fall into this category.
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 |
|---|---|---|
| LeptinAssessment of salivary and serum leptin levels in oral lichen planus patients and healthy controls | Diagnostic test | Healthy control group, Oral lichen planus patients |
Primary outcome
Serum Leptin Level
Time frame: Baseline
Assessment of serum leptin levels in in oral lichen planus patients
1 secondary outcome
Salivary Leptin Levels
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35685585Aryanian Z, Shirzadian A, Hatami P, Dadras H. High Incidence of Metabolic Syndrome Components in Lichen Planus Patients: A Prospective Cross-Sectional Study. Int J Clin Pract. 2022 Jan 31;2022:7184678. doi: 10.1155/2022/7184678. eCollection 2022.
- Background: PubMed 15749839Matarese G, Moschos S, Mantzoros CS. Leptin in immunology. J Immunol. 2005 Mar 15;174(6):3137-42. doi: 10.4049/jimmunol.174.6.3137.
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
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Not yet recruiting
Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
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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.
Weam Ah Rashwan, PHD study director
Cairo University
Olfat Ga Shaker, PHD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Lichen Planus and Leptin Levels, run by Cairo University 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 30 Mar 2025. 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?
Yes. Results are posted in the registry (first posted 30 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Serum Leptin Level (time frame: Baseline). 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 NCT06078579, which also lists 2 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 30 Mar 2025.