Adjunctive Oral Systemic Vitamin E Therapy on Salivary Nitric Oxide Level in Patients With Erosive Oral Lichen Planus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-20

Study Completion Date

2023-03-05

Brief Summary

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Oral lichen planus (OLP) is a chronic inflammatory disease affecting the skin, mucous membranes,s and rarely scalp and nails. It is a T-cell-mediated autoimmune disease. Traditional treatment for OLP is topical steroids commonly used to treat mild to moderately symptomatic lesions. Recent treatment modalities for oral lichen planus include micronutrients such as antioxidants including vitamin E that modify the immune system function. The aim of this study is to evaluate the efficacy of adjunctive oral systemic vitamin E therapy on salivary nitric oxide levels in patients with erosive oral lichen planus.

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Detailed Description

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Conditions

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Lichen Planus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Topical corticosteroid and Vitamin E

Group Type EXPERIMENTAL

Topical corticosteroid and Vitamin E

Intervention Type DRUG

26 patients who will administrate topical corticosteroid: triamcinolone acetonide 1% oral gel "Kenacort-A Orabase" \* three times daily for 8 weeks applied after meals and at night with avoidance of foods and drinks for 30 minutes after the application. In addition to one capsule of 400 mg oral systemic vitamin E supplement\* will be prescribed once daily at the morning

Topical corticosteroid

Group Type ACTIVE_COMPARATOR

Topical corticosteroid

Intervention Type DRUG

26 patients will administrate topical corticosteroid: triamcinolone acetonide 1% oral gel "Kenacort-A Orabase" three times daily for 8 week that will be applied after meals and at night with avoidance of foods and drinks for 30 minutes after the application

Interventions

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Topical corticosteroid and Vitamin E

26 patients who will administrate topical corticosteroid: triamcinolone acetonide 1% oral gel "Kenacort-A Orabase" \* three times daily for 8 weeks applied after meals and at night with avoidance of foods and drinks for 30 minutes after the application. In addition to one capsule of 400 mg oral systemic vitamin E supplement\* will be prescribed once daily at the morning

Intervention Type DRUG

Topical corticosteroid

26 patients will administrate topical corticosteroid: triamcinolone acetonide 1% oral gel "Kenacort-A Orabase" three times daily for 8 week that will be applied after meals and at night with avoidance of foods and drinks for 30 minutes after the application

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who are clinically and histopathologically confirmed of having erosive OLP according to modified WHO criteria.
* Patients with erosive OLP patients who will agree to take supplied medications.
* Ability to complete this trial.

Exclusion Criteria

* OLP patients receiving any systemic treatment such as systemic steroids, other immunosuppressive drugs, or non-steroidal anti-inflammatory drugs on past 3 months.
* Pregnant and breast-feeding females.
* Patients suffering from systemic diseases.
* Patients with lesions showing any dysplastic changes in the biopsy specimen.
* Patients who are smoking and tobacco users in any form, will not be included.
* Patients with both lichenoid contact reaction and lichenoid drug reactions.
* Patients with cutaneous lichen planus lesions

Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No