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

• Sponsor: Hams Hamed Abdelrahman (Other)
• Overall Status: Completed
• CT.gov ID: NCT05787925
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.5
• Patients Per Site Per Month: 11.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lichen Planus	Drug: Topical corticosteroid and Vitamin E; Drug: Topical corticosteroid	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: 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)
• Actual Study Start Date: Oct 20, 2022
• Actual Primary Completion Date: Mar 5, 2023
• Actual Study Completion Date: Mar 5, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in oral lesion [At baseline,4th week and 8th week]

   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

2. Change in pain score [At baseline,4th week and 8th week]

   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)

Secondary Outcome Measures

1. Change in salivary nitric oxide [At baseline,4th week and 8th week]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexandria Faculty of Dentistry	Alexandria		Egypt

Sponsors and Collaborators

• Hams Hamed Abdelrahman

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician, Alexandria University
• ClinicalTrials.gov Identifier: NCT05787925
• Other Study ID Numbers: 0475-08
• First Posted: Mar 28, 2023
• Last Update Posted: Mar 28, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lichen Planus, Oral; Lichen Planus; Vitamin E

Study Results

No Results Posted as of Mar 28, 2023