## Protocol Section
### Identification Module
**NCT ID:** NCT06078579

**Brief Title:** Salivary and Serum Leptin Levels in Oral Lichen Planus Patients: A Case-control Study.

**Official Title:** Salivary and Serum Leptin Levels in Oral Lichen Planus Patients: A Case-Control Study.

#### Organization Study ID Info
**ID:** 20723
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2024-12-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-06

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-05

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-12-30

**Type:** ACTUAL

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2023-10-12
**Type:** ACTUAL
**Study First Submit Date:** 2023-09-27
**Study First Submit QC Date:** 2023-10-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Cairo University

#### Responsible Party

**Investigator Affiliation:** Cairo University

**Investigator Full Name:** Bahaa Mahmoud Fawzy El Nomrosy

**Investigator Title:** Dentist

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Oral Lichen Planus

- Leptin Levels

**Keywords:**

- salivary

- Serum

### Design Module

#### Bio Spec

**Description:** ELISA

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** OTHER

#### Enrollment Info

**Count:** 79

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Assessment of salivary and serum leptin levels

**Intervention Names:**

- Diagnostic Test: Leptin

**Label:** Oral lichen planus patients

#### Arm Group 2

**Description:** Assessment of salivary and serum leptin levels

**Intervention Names:**

- Diagnostic Test: Leptin

**Label:** Healthy control group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Healthy control group

- Oral lichen planus patients

**Description:** Assessment of salivary and serum leptin levels in oral lichen planus patients and healthy controls

**Name:** Leptin

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** Assessment of serum leptin levels in in oral lichen planus patients

**Measure:** Serum leptin level

**Time Frame:** Baseline

#### Secondary Outcomes

**Description:** Assessment of salivary leptin levels in oral lichen planus patients

**Measure:** Salivary leptin levels

**Time Frame:** Baseline

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

**Healthy Volunteers:** True

**Maximum Age:** 70 Years

**Minimum Age:** 30 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** bahaa.fawzy@dentistry.cu.edu.eg

**Name:** Bahaa Ma El Nomrosy, Master

**Phone:** +201033559646

**Role:** CONTACT

**Contact 2:**

**Email:** alaa.ashraf.s2@gmail.com

**Name:** Alaa As El shazly, Bachelor

**Phone:** 01010223663

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Cairo

**Country:** Egypt

**Facility:** Cairo university

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Cairo University

**Name:** Weam Ah Rashwan, PHD

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Cairo University

**Name:** Olfat Ga Shaker, PHD

**Role:** STUDY_DIRECTOR

### References Module

#### Available IPDs

**Comment:** www.researchgate.net/publication/344178013_Serum_Leptin_and_Lipid_Profile_in_Lichen_Planus_A_case_control_study

**Type:** Study Protocol

**URL:** https://www.ijhsr.org/IJHSR_Vol.5_Issue.10_Oct2015/20.pdf

#### References

**Citation:** 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.

**PMID:** 35685585

**Citation:** Matarese G, Moschos S, Mantzoros CS. Leptin in immunology. J Immunol. 2005 Mar 15;174(6):3137-42. doi: 10.4049/jimmunol.174.6.3137.

**PMID:** 15749839

## Document Section

### Large Document Module

#### Large Docs

- Date: 2023-07-18

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 658536

- Type Abbrev: Prot

- Upload Date: 2023-10-06T03:55

- Date: 2023-07-10

- Filename: SAP_001.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 740731

- Type Abbrev: SAP

- Upload Date: 2023-10-09T10:25

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000017512

- Term: Lichenoid Eruptions

- ID: D000017444

- Term: Skin Diseases, Papulosquamous

- ID: D000012871

- Term: Skin Diseases

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M19896

- Name: Lichen Planus, Oral

- Relevance: HIGH

- As Found: Oral Lichen Planus

- ID: M11012

- Name: Lichen Planus

- Relevance: HIGH

- As Found: Lichen Planus

- ID: M19775

- Name: Lichenoid Eruptions

- Relevance: LOW

- As Found: Unknown

- ID: M8219

- Name: Exanthema

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M19713

- Name: Skin Diseases, Papulosquamous

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000017676

- Term: Lichen Planus, Oral

- ID: D000008010

- Term: Lichen Planus

### Misc Info Module

- Version Holder: 2024-05-24
