FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/10/096658 [Registered on: 30/10/2025] Trial Registered Prospectively
Last Modified On: 27/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Do People with Mucosal Lichen Planus Have a Higher Risk of Metabolic Syndrome? 
Scientific Title of Study   Prevalence of Metabolic Syndrome in Patients with Mucosal Lichen Planus 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Benita Edith Chelliah 
Designation  Postgraduate Resident  
Affiliation  St.Johns Medical College Hospital 
Address  Room 43, St.Johns Medical College Hospital, Koramangala, Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  7219504440  
Fax    
Email  benitachelliah@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prathibha J P 
Designation  Associate Professor, Department of Dermatology, St.Johns Medical College Hospital 
Affiliation  St.Johns Medical College Hospital 
Address  Department of Dermatology, St Johns Medical College Hospital, Sarjapur Road,Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  9886695980  
Fax    
Email  prathibha.jp@stjohns.in  
 
Details of Contact Person
Public Query
 
Name  Prathibha J P 
Designation  Associate Professor, Department of Dermatology, St.Johns Medical College Hospital 
Affiliation  St.Johns Medical College Hospital 
Address  Department of Dermatology, St Johns Medical College Hospital, Sarjapur Road, Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  9886695980  
Fax    
Email  prathibha.jp@stjohns.in  
 
Source of Monetary or Material Support  
St.Johns Medical College Hospital, Sarjapur Road , Bangalore 560034 , Karnataka , India  
 
Primary Sponsor  
Name  Benita Edith Chelliah 
Address  Room 43, Mother Teresa Hostel , St.Johns Medical College Hospital , Bangalore - 560034 
Type of Sponsor  Other [Self ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Benita Edith Chelliah  St.Johns Medical College Hospital  Department of Dermatology, St.Johns Medical College Hospital, Sarjapur Road , Koramangala , Bangalore 560034
Bangalore
KARNATAKA 
7219504440

benitachelliah@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of St.Johns National Academy of Health Sciences   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Metabolic Syndrome 
Patients  (1) ICD-10 Condition: L438||Other lichen planus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  I) Patients aged 18 years and above diagnosed with
mucosal lichen planus (clinically or
histopathologically confirmed)
2) Healthy individuals without Lichen Planus or systemic
inflammatory diseases as controls. 
 
ExclusionCriteria 
Details  1) Patients on systemic steroids, retinoids
2) Pregnant and lactating women
3) Patients with Autoimmune or Chronic Inflammatory
conditions 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the prevalence of metabolic syndrome in patients with mucosal lichen planus  End of study period  
 
Secondary Outcome  
Outcome  TimePoints 
To identify local factors influencing Mucosal Lichen Planus  End of study period  
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Lichen planus LP is an idiopathic, chronic inflammatory disease affecting the skin and mucosal membranes, with the oral mucosa being the most commonly involved site. Mucosal lichen planus MLP, particularly oral and vulvovaginal forms, often runs a relapsing course and may be associated with systemic inflammatory processes. Emerging evidence suggests a possible link between mucosal lichen planus and metabolic syndrome MS due to shared pathogenic mechanisms involving chronic inflammation, oxidative stress, and immune dysregulation mediated by cytokines such as TNF alpha, IL 6, and C reactive protein CRP.


Metabolic syndrome represents a global health burden characterized by central obesity, insulin resistance, dyslipidemia, and hypertension, which predispose individuals to cardiovascular morbidity and diabetes. Identifying a potential association between mucosal LP and MS could have important clinical implications, emphasizing the need for early metabolic screening and intervention in dermatological practice.


This descriptive cross sectional study aims to determine the prevalence of metabolic syndrome in patients with mucosal lichen planus and to identify local factors influencing the disease. The study will be conducted in the Department of Dermatology, St Johns Medical College Hospital, Bengaluru, over a period of about 2 years. A total of 70 participants will be included, 35 clinically or histopathologically confirmed mucosal LP cases and 35 age and sex matched healthy controls.


Participants will undergo clinical evaluation and biochemical investigations including fasting blood glucose, lipid profile, waist circumference, and blood pressure measurement. Metabolic syndrome will be diagnosed using NCEP ATP III South Asian cut off criteria. Data will be analyzed using SPSS version 25 with appropriate statistical tests Chi square or Fishers exact test for categorical variables and t test or Mann Whitney U test for continuous variables, and a p value less than 0.05 will be considered statistically significant.


This study seeks to contribute to existing literature by providing evidence based insights into the prevalence of metabolic abnormalities among patients with mucosal lichen planus, thereby promoting integrated dermatological and systemic care to reduce long term cardiometabolic risks. 

 
Close