Efficacy of Green Tea Buccal Tablets in Oral Lichen Planus

• ClinicalTrials.gov Identifier: NCT03415165
• Recruitment Status: Unknown
• First Posted: January 30, 2018
• Last Update Posted: February 13, 2018
• Sponsor: Cairo University
• Information provided by (Responsible Party): Esraa Magdy, Cairo University

Study Description

Brief 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

Condition or disease	Intervention/treatment	Phase
Oral Lichen Planus	Drug: green tea buccal tablet; Drug: Corticosteroids Topical	Early Phase 1

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 .

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: January 3, 2018
• Estimated Primary Completion Date: January 30, 2019
• Estimated Study Completion Date: January 30, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: green tea buccal tablet; buccal tablet 3 times aday	Drug: green tea buccal tablet; buccal tablet for 8 hrs 3 times aday; Other Name: catechines
Sham Comparator: corticosteroids topical; topical steroids 3 times aday	Drug: Corticosteroids Topical; kenacort in orabase 4 times aday; Other Name: local corticosteroids

Outcome Measures

Primary Outcome Measures :

1. size of the lesion [ Time Frame: 12 weeks ]
   the shape and the measurement of its size

Secondary Outcome Measures :

1. visual analogue score [ Time Frame: 12 weeks ]
   pain score from 0 to 10

Eligibility Criteria

• Ages Eligible for Study: 17 Years to 80 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: EMagdy baligh, master; 01003329610; esraa_magdy@dentistry.cu.edu.eg

Contact: esraa baligh, master; 01003329610; esraa_magdy@dentistry.cu.edu.eg

Locations

Egypt

Cairo University; Recruiting

Cairo, Egypt, 00202

Contact: cairo university ethics@dentistry.cu.edu.eg

Contact: cairo university

Sponsors and Collaborators

Cairo University

Investigators

• Study Chair: cairo university; cu

More Information

• Responsible Party: Esraa Magdy, princible investigator EMagdy, Cairo University
• ClinicalTrials.gov Identifier: NCT03415165
• Other Study ID Numbers: 161187
• First Posted: January 30, 2018
• Last Update Posted: February 13, 2018
• Last Verified: January 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Lichen Planus, Oral; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Mouth Diseases; Stomatognathic Diseases