NCT06078579

Brief Summary

This study aims to evaluate the levels of leptin in both saliva and serum samples of patients diagnosed with oral lichen.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

December 30, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
3 months until next milestone

Results Posted

Study results publicly available

March 30, 2025

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

11 months

First QC Date

September 27, 2023

Results QC Date

February 4, 2025

Last Update Submit

March 28, 2025

Conditions

Keywords

salivarySerum

Outcome Measures

Primary Outcomes (1)

  • Serum Leptin Level

    Assessment of serum leptin levels in in oral lichen planus patients

    Baseline

Secondary Outcomes (1)

  • Salivary Leptin Levels

    Baseline

Study Arms (2)

Oral lichen planus patients

Assessment of salivary and serum leptin levels

Diagnostic Test: Leptin

Healthy control group

Assessment of salivary and serum leptin levels

Diagnostic Test: Leptin

Interventions

LeptinDIAGNOSTIC_TEST

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

Healthy control groupOral lichen planus patients

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, Egypt

Location

Related Publications (2)

  • 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: 35685585BACKGROUND
  • 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: 15749839BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

ELISA

MeSH Terms

Conditions

Lichen Planus, Oral

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesLichen PlanusLichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Dr. Bahaa Mahmoud Fawzy
Organization
Cairo university

Study Officials

  • Weam Ah Rashwan, PHD

    Cairo University

    STUDY DIRECTOR
  • Olfat Ga Shaker, PHD

    Cairo University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist

Study Record Dates

First Submitted

September 27, 2023

First Posted

October 12, 2023

Study Start

December 30, 2023

Primary Completion

November 30, 2024

Study Completion

December 30, 2024

Last Updated

March 30, 2025

Results First Posted

March 30, 2025

Record last verified: 2025-03

Locations