Efficacy of Green Tea Buccal Tablets in Oral Lichen Planus

NCT03415165 | Unknown Early Phase 1

• 1 other identifier: 161187
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Oral Lichen Planus

Outcome Measures

Primary Outcomes (1)

• size of the lesion

  the shape and the measurement of its size

  12 weeks

Secondary Outcomes (1)

• visual analogue score

  12 weeks

Study Arms (2)

green tea buccal tablet

ACTIVE COMPARATOR

buccal tablet 3 times aday

Drug: green tea buccal tablet

corticosteroids topical

SHAM COMPARATOR

topical steroids 3 times aday

Drug: Corticosteroids Topical

Interventions

green tea buccal tablet DRUG

buccal tablet for 8 hrs 3 times aday

Also known as: catechines

green tea buccal tablet

Corticosteroids Topical DRUG

kenacort in orabase 4 times aday

Also known as: local corticosteroids

corticosteroids topical

Eligibility Criteria

• Age: 17 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 00202, Egypt

RECRUITING

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• cairo university

  cu

  STUDY CHAIR

Central Study Contacts

EMagdy baligh, master

CONTACT

01003329610; esraa_magdy@dentistry.cu.edu.eg

esraa baligh, master

CONTACT

01003329610; esraa_magdy@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: princible investigator EMagdy

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: January 30, 2018
• Study Start: January 3, 2018
• Primary Completion: January 30, 2019
• Study Completion: January 30, 2019
• Last Updated: February 13, 2018

Record last verified: 2018-01

Locations

EG (1)