Trial Outcomes & Findings for Salivary and Serum Leptin Levels in Oral Lichen Planus Patients: A Case-control Study. (NCT NCT06078579)

NCT ID: NCT06078579

Last Updated: 2025-03-30

Results Overview

Assessment of serum leptin levels in in oral lichen planus patients

• Recruitment status: COMPLETED
• Target enrollment: 78 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2025-03-30

Participant Flow

The recruitment process has taken 1 year, starting from December 2023 till December 2024; all recruitment processes were done in the Cairo University outpatient clinic.

There is no washout that has been done; some of the enrolled participants were excluded because they were currently on systemic steroid medication or taking topical steroids for lesions.

Participant milestones

Measure	Oral Lichen Planus Patients Assessment of salivary and serum leptin levels Leptin: Assessment of salivary and serum leptin levels in oral lichen planus patients	Healthy Control Group Assessment of salivary and serum leptin levels Leptin: Assessment of salivary and serum leptin healthy controls
Overall Study STARTED	39	39
Overall Study COMPLETED	39	39
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Oral Lichen Planus Patients n=39 Participants Assessment of salivary and serum leptin levels Leptin: Assessment of salivary and serum leptin levels in oral lichen planus patients and healthy controls	Healthy Control Group n=39 Participants Assessment of salivary and serum leptin levels Leptin: Assessment of salivary and serum leptin levels in oral lichen planus patients and healthy controls	Total n=78 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=39 Participants	0 Participants n=78 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=39 Participants	38 Participants n=39 Participants	69 Participants n=78 Participants
Age, Categorical >=65 years	8 Participants n=39 Participants	1 Participants n=39 Participants	9 Participants n=78 Participants
Age, Continuous	50.77 years STANDARD_DEVIATION 13.37 • n=39 Participants	34.51 years STANDARD_DEVIATION 12.53 • n=39 Participants	42.641 years STANDARD_DEVIATION 12.87 • n=78 Participants
Sex: Female, Male Female	26 Participants n=39 Participants	21 Participants n=39 Participants	47 Participants n=78 Participants
Sex: Female, Male Male	13 Participants n=39 Participants	18 Participants n=39 Participants	31 Participants n=78 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Egypt	39 Participants n=39 Participants	39 Participants n=39 Participants	78 Participants n=78 Participants
Body mass index	28.47 Kg/m^2 STANDARD_DEVIATION 3.95 • n=39 Participants	28.77 Kg/m^2 STANDARD_DEVIATION 3.32 • n=39 Participants	28.62 Kg/m^2 STANDARD_DEVIATION 3.62 • n=78 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Levels of leptin in serum of patients with active oral lichen planus

Assessment of serum leptin levels in in oral lichen planus patients

Outcome measures

Measure	Serum Leptin Levels in OLP Patients n=39 Participants Leptin levels in serum of patients with active oral lichen planus disease	Serum Leptin Levels in Healthy Control Subjects n=39 Participants Serum leptin levels measurement in healthy control subjects
Serum Leptin Level	13.23 ng/ml Standard Deviation 7.29	4.20 ng/ml Standard Deviation 1.23

SECONDARY outcome

Timeframe: Baseline

Assessment of salivary leptin levels in oral lichen planus patients

Outcome measures

Measure	Serum Leptin Levels in OLP Patients n=39 Participants Leptin levels in serum of patients with active oral lichen planus disease	Serum Leptin Levels in Healthy Control Subjects n=39 Participants Serum leptin levels measurement in healthy control subjects
Salivary Leptin Levels	15.31 ng/ml Standard Deviation 6.59	4.90 ng/ml Standard Deviation 1.26

Adverse Events

Oral Lichen Planus Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Control Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Bahaa Mahmoud Fawzy

Cairo university

Phone: +201033559646

Email: bahaamust66@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place