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

The Efficacy of Adjunctive Oral Systemic Vitamin E Therapy on Salivary Nitric Oxide Level In Patients With Erosive Oral Lichen Planus (A Randomized Controlled Clinical Trial)

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.

Study Overview

• Status: Completed
• Conditions: Lichen Planus
• Intervention / Treatment: Drug: Topical corticosteroid and Vitamin E; Drug: Topical corticosteroid

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical corticosteroid and Vitamin E	Drug: 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
Active Comparator: Topical corticosteroid	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in oral lesion	whole treatment response and the size of the oral lesions will be recorded using Thongprasom et al. scoring system, score 5 was assigned to patients having white striae with erosive areas >1 cm2, score 4 for patients with white striae and erosive areas <1 cm2, score 3 for those having white striae and atrophic areas >1 cm2, score 2 for those having white striae and atrophic areas <1 cm2, score 1 for those having only white striae, and score 0 for normal mucosa	At baseline,4th week and 8th week
Change in pain score	At baseline, 4th week and 8th week after the treatment, burning sensation using Visual Analogue Scale (VAS) will be measured on a 10-point (0 = no symptoms, 10 = severe pain)	At baseline,4th week and 8th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in salivary nitric oxide	Patients will be asked to rinse their mouth with 5 ml of normal saline for 3 min then tilt their head forward and expectorate saliva into a sterile beaker without swallowing. The saliva samples will be stored at -20 ºC till the time of analysis. It depends on the addition of Griess Reagents which convert nitrite into a deep purple azo compound; photometric measurement of the absorbance due to this azo chromophore accurately determines NO2-concentration	At baseline,4th week and 8th week

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2022
• Primary Completion (Actual): March 5, 2023
• Study Completion (Actual): March 5, 2023

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Stomatognathic Diseases; Mouth Diseases; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Lichen Planus, Oral; Lichen Planus; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin E
• Other Study ID Numbers: 0475-08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No