Suspended

Efficacy of 200mg and 300mg Concentrates of Green Tea Polyphenols Using Buccal Tablets Versus Topical Application of Corticosteroids in Treatment of Patients With Symptomic Oral Lichen Planus Randomized Clinical Trial

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What is being tested

green tea buccal tablet

+ Corticosteroids Topical

Drug
Who is being recruted

Lichen Planus+5

+ Stomatognathic Diseases

+ Mouth Diseases

From 17 to 80 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledEarly Phase 1
Interventional
Study Start: January 2018
See protocol details

Summary

Principal SponsorCairo University
Study ContactEMagdy baligh, masterMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 3, 2018

Actual date on which the first participant was enrolled.

* Each patient was informed about the detailed procedure, and educated about benefits of the treatment, the known side effects and follow-up appointments needed. After that, each subject participating in the study signed an informed written consent form. * Subjects were given freedom to leave the study at any time when they need to. Group A (Experimental group) 200 mg green tea Where patients in this group will receive a buccal tablet containing 200 mg of green tea extract which adheres to the buccal mucosa slowly releasing the polyphenoles along around 8 hours 2 times aday for four weeks. Preparation of buccal tablets : Mucoahesive buccal tablets is prepared by a direct compression procedure. Various batches are prepared by varying the chitosan:drug ratio to identify the most effective formulation. The mucoadhesive drug/polymer mixture is prepared by homogeneous mixing of the drug with chitosan , secondary polymer, and D-mannitol, in a glass mortar for 15 min. Then, Mg stearate will be added and mixed for 5 min .The mixture is compressed using a tablet machine (Type EK: O.Erweka apparatus, Frankfurt, Germany) using flat-tip punches and dies with 8-mm-diameter. Each tablet weighed 212 mg with a thickness of 3.1 mm.( Darwish and Elmeshad,2009) Group B (Experimental group) 300 mg green tea Where patients in this group will receive a buccal tablet containing 300 mg of green tea extract which adheres to the buccal mucosa slowly releasing the polyphenoles along around 8 hours 2 times aday for four weeks. Group C (Control group) corticosteroid group: Where patients are treated with topical corticosteroids 1 mg/g Triamcinolone acetonide (Kenacort-A orabase 20 G Pomad: Deva dermatological product,Turkey) applied topically 4 times a day i.e. following each meal and at bed time for four weeks .

Official TitleEfficacy of 200mg and 300mg Concentrates of Green Tea Polyphenols Using Buccal Tablets Versus Topical Application of Corticosteroids in Treatment of Patients With Symptomic Oral Lichen Planus Randomized Clinical Trial
Principal SponsorCairo University
Study ContactEMagdy baligh, masterMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 17 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Lichen PlanusStomatognathic DiseasesMouth DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, PapulosquamousLichenoid EruptionsLichen Planus, Oral

Criteria

5 inclusion criteria required to participate
Symptomatic lesions.

OLP lesions with the diagnosis confirmed both clinically and histopathologically.

Clinical score higher than 3.

Disease duration of more than 2 months.

Show More Criteria

8 exclusion criteria prevent from participating
Presence of any visible oral lesion other than OLP.

Pregnant or breast-feeding women,

Immuno-deficiency diseases.

Current malignancy or malignancy in history.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
buccal tablet 3 times aday

Group II

Sham
topical steroids 3 times aday

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Cairo University

Cairo, EgyptOpen Cairo University in Google Maps
SuspendedOne Study Center