Efficacy of Green Tea Buccal Tablets in Oral Lichen Planus

Cairo University (CU)

Status and phase: Unknown; Early Phase 1

Conditions: Oral Lichen Planus

Treatments: Drug: green tea buccal tablet; Drug: Corticosteroids Topical

Study type: Interventional

Funder types: Other

Identifiers

NCT03415165

161187

Details and patient eligibility

About

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

Full 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 .

Enrollment: 60 estimated patients

Sex: All

Ages: 17 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic lesions.
• OLP lesions with the diagnosis confirmed both clinically and histopathologically.
• Clinical score higher than 3.
• Disease duration of more than 2 months.
• Absence of dysplasia in histological section

Exclusion criteria

• Presence of any visible oral lesion other than OLP.
• Pregnant or breast-feeding women,
• Immuno-deficiency diseases.
• Current malignancy or malignancy in history.
• Concomitant treatment potentially effective on OLP within the previous 2 months such as antimalarial agents, retinoids, corticosteroids or immunosuppressive drugs.
• Severe or recurrent infections.
• Lichenoid reaction.
• Patients presents with skin lesions which may require systemic corticosteroid therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

green tea buccal tablet

Active Comparator group

Description:

buccal tablet 3 times aday

Treatment:

Drug: green tea buccal tablet

corticosteroids topical

Sham Comparator group

Description:

topical steroids 3 times aday

Treatment:

Drug: Corticosteroids Topical