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

H

Hams Hamed Abdelrahman

Status

Completed

Conditions

Lichen Planus

Treatments

Drug: Topical corticosteroid and Vitamin E
Drug: Topical corticosteroid

Study type

Interventional

Funder types

Other

Identifiers

NCT05787925
0475-08

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

All

Ages

30 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

52 participants in 2 patient groups

Topical corticosteroid and Vitamin E
Experimental group
Treatment:
Drug: Topical corticosteroid and Vitamin E
Topical corticosteroid
Active Comparator group
Treatment:
Drug: Topical corticosteroid

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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