NCT03415165

Efficacy of Green Tea Buccal Tablets in Oral Lichen Planus

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 17 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Is topical application of green tea polyphenols buccal tablet more effective in treatment of patients with symptomatic oral lichen planus in comparison with topical application of corticosteroids and what is the most effective concentration of polyphenols

Detailed description

* 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 .

Conditions

• Oral Lichen Planus

Interventions

Type	Name	Description
DRUG	green tea buccal tablet	buccal tablet for 8 hrs 3 times aday
DRUG	Corticosteroids Topical	kenacort in orabase 4 times aday

Timeline

• Start date: 2018-01-03
• Primary completion: 2019-01-30
• Completion: 2019-01-30
• First posted: 2018-01-30
• Last updated: 2018-02-13

Locations

1 site across 1 country: Egypt