| 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
|
|
|
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
|
|
|
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. |