Prospective Single-center Study of a Cohort of Patients With Oral Lichen Planus: Cardiovascular and Prothrombotic Risk in Patients With Oral Lichen Planus (OLP).
Conditions: Oral Lichen Planus
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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STUDY SYNOPSIS 
 
 
 
STUDY TITLE 
Prospective monocentric study of a cohort of patients affected by Oral Lichen Planus: 
Cardiovascular and prothrombotic risk in patients affected by Oral Lichen Planus (OLP). 
 
 
 
SPONSOR 
 
FPG (Fondazione Policlinico Universitario A. Gemelli IRCCS) 
 
 
 
CRO 
 
/ 
 
 
 
Co-Funder 
 
/ 
 
 
 
PRINCIPAL INVESTIGATOR 
 
Prof. Carlo Lajolo 
 
 
 
SINGLE ETHICS COMMITTEE OPINION 
 
Yes 
 
 
 
BACKGROUND AND RATIONALE 
 
Oral Lichen Planus (OLP) is an autoimmune disease of unknown etiology, in which a lymphocytic 
response occurs against unknown antigens located in the basal and suprabasal layers of the oral 
mucosal epithelium. It is a chronic and incurable condition now classified as a potentially malignant 
disorder, with an increased risk of malignant transformation over time. 

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OLP affects approximately 2% of the global population, with increasing prevalence after age 40. 
Two main clinical forms have been described: one with hyperkeratotic, mostly asymptomatic 
lesions, and another with atrophic and erosive lesions often causing significant discomfort. 
 
 
 
In recent years, cardiovascular risk has been associated with various dermatological conditions, and 
some studies have shown a possible association between lichen planus and dyslipidemia, as well as 
increased prevalence of atherosclerosis. Patients with OLP may present with higher levels of 
cardiovascular and metabolic risk markers compared to the general population, likely due to chronic 
inflammation. 
 
 
 
Moreover, a strong association between immune system diseases and increased cardiovascular risk 
is already known. A recent Danish study involving 3,322 patients with autoimmune diseases found 
increased cardiovascular risks (e.g., cardiac arrest, cardiac atherosclerosis, venous 
thromboembolism, arrhythmia) in patients with cutaneous and oral vesiculobullous diseases. 
 
 
 
STUDY OBJECTIVES 
 
 
 
Primary Objective: 
 
To evaluate the cardiovascular profile and the risk of thrombotic events in patients affected by Oral 
Lichen Planus. 
 
 
Secondary Objectives: 
 
To identify which markers and factors are most representative in assessing vascular risk in OLP 
patients. 
 
 
ENDPOINTS 
 
 
 
Primary Endpoint: 
 
Prevalence of thrombotic risk. 
 
 
 
Secondary Endpoints: 

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• 
Evaluation of thrombophilia screening parameters, antiphospholipid antibody levels, and 
platelet aggregability in a cohort of OLP patients. 
• 
Association between collected parameters and incidence of thrombotic damage. 
 
 
 
STUDY DESIGN 
 
Single-center prospective observational study. 
 
 
 
NUMBER OF PATIENTS 
 
55 patients at FPG. 
 
 
 
TARGET POPULATION 
 
Patients diagnosed with Oral Lichen Planus. 
 
 
 
INCLUSION CRITERIA 
 
• 
Clinical and histological diagnosis of Oral Lichen Planus 
• 
Age > 18 years 
• 
Signed informed consent 
 
 
 
EXCLUSION CRITERIA 
 
• 
Patients < 18 years old 
• 
Refusal to sign informed consent 
• 
No diagnosis of OLP 
• 
Known cardiac diseases 
• 
History of major cardiovascular events (myocardial infarction, ischemic stroke, TIA) 
• 
Established heart failure (NYHA class III–IV) 
• 
Cardiomyopathies unrelated to the studied risk factors (e.g., genetic hypertrophic 
cardiomyopathy) 
• 
Anticoagulant therapy 
• 
Primary or secondary diseases associated with increased cardiovascular risk 
 
 
 
STUDY DURATION AND ENROLLMENT PERIOD 

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Following Ethics Committee approval, the study will last 18 months: 12 months for consecutive 
enrollment of OLP patients and 6 months for data analysis. 
 
 
STUDY PROCEDURES 
Patients with a confirmed diagnosis of Oral Lichen Planus will undergo thrombophilia screening 
and cardiovascular risk assessment via hematological and laboratory tests. 
 
 
STATISTICAL ANALYSIS AND SAMPLE SIZE 
 
Sample size was calculated based on the simple random sampling formula. Assuming a 3.7% 
prevalence of prothrombotic risk in OLP patients and a desired absolute precision of 5%, a sample 
of 55 patients is required. 
 
 
 
The primary endpoint (thrombotic risk prevalence) will be reported with a 95% confidence interval. 
The sample’s clinical and demographic characteristics will be described using descriptive statistics. 
Qualitative variables will be reported as absolute and percentage frequencies; quantitative variables 
will be reported as means and standard deviations (SD) if normally distributed, or as medians and 
interquartile ranges (IQR) otherwise. Normality will be assessed using the Shapiro-Wilk test. 
 
 
 
Associations between qualitative variables will be assessed using Fisher’s exact test or the chi- 
square test, as appropriate. Quantitative variable differences will be tested using Student’s t-test or 
the Mann-Whitney U test depending on normality assumptions. 
 
 
A p-value < 0.05 will be considered statistically significant. Statistical analyses will be performed 
using SPSS version 25.0 (Chicago, IL, USA). 
 
 
SAFETY / ADVERSE EVENT MANAGEMENT 
Patients will be treated according to routine clinical practice. No study-specific procedures will be 
performed. 
 
 
REFERENCE DOCUMENT FOR SAFETY 
 
N/A 

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BIBLIOGRAPHY 
1. González-Moles, M. Á., & Ramos-Garcia, P. (2021). J Clin Med, 10(22), 5383. 
2. González-Moles, Á., et al. (2019). Oral Oncol, 96, 121-130. 
3. Warnakulasuriya, S., et al. (2021). Oral Dis, 27(8), 1862-1880. 
4. González-Moles, M. A., et al. (2021). Oral Dis, 27(4), 813-828. 
5. Carbone M, et al. (2009). Oral Dis, 15(3):235-43. 
6. Padhi T, Garima (2013). Indian J Dermatol, 58: 299-305. 
7. Dreiher J, et al. (2009). Br J Dermatol, 161(3):626-9. 
8. Arias-Santiago S, et al. (2011). Am J Med, 124: 543-548. 
9. Aksu F, et al. (2016). Can J Cardiol, 32:1246.1-1246.6. 
10. Saleh N, et al. (2014). J Eur Acad Dermatol Venereol, 28: 1507-1513. 
11. Krishnamoorthy B, et al. (2014). J Clin Diagn Res, 8: ZC92-95. 
12. Bonnesen K, et al. (2024). J Am Acad Dermatol. doi:10.1016/j.jaad.2024.02.052. 
13. Huang YH, et al. (2012). J Invest Dermatol, 132(1):92-7. 
14. Kridin K, et al. (2017). Acta Derm Venereol, 97(5):607-611.