Efficacy of Green Tea Buccal Tablets in Oral Lichen Planus

Oral Lichen Planus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03415165
• Other study ID #: 161187
• Status: Recruiting
• Phase: Early Phase 1
• First received: January 22, 2018
• Last updated: February 11, 2018
• Start date: January 3, 2018
• Est. completion date: January 30, 2019

Study information

• Verified date: January 2018
• Source: Cairo University
• Contact: EMagdy baligh, master
• Phone: 01003329610
• Email: esraa_magdy[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 30, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral
• Oral Lichen Planus

Intervention

Drug:
• green tea buccal tablet
buccal tablet for 8 hrs 3 times aday
• Corticosteroids Topical
kenacort in orabase 4 times aday

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	size of the lesion	the shape and the measurement of its size	12 weeks
Secondary	visual analogue score	pain score from 0 to 10	12 weeks