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

NCT05787925 | Completed

• 1 other identifier: 0475-08
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lichen Planus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in salivary nitric oxide

  At baseline,4th week and 8th week

Study Arms (2)

Topical corticosteroid and Vitamin E

EXPERIMENTAL

Drug: Topical corticosteroid and Vitamin E

Topical corticosteroid

ACTIVE COMPARATOR

Drug: Topical corticosteroid

Interventions

Topical corticosteroid and Vitamin E 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 and Vitamin E

Topical corticosteroid 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

Topical corticosteroid

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

MeSH Terms

Conditions

Lichen Planus

Interventions

Adrenal Cortex Hormones; Vitamin E

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 28, 2023
• Study Start: October 20, 2022
• Primary Completion: March 5, 2023
• Study Completion: March 5, 2023
• Last Updated: March 28, 2023

Record last verified: 2023-03

Locations

EG (1)