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Active, Not Recruiting

NCT Number: NCT06060301

Topical Sulfasalazine and Oral Lichen Planus

Oral lichen planus (OLP) is a chronic inflammatory disease that affects the mucosal membrane. T-cell mediated damage against the mucosal epithelial cells is implicated in the pathogenesis of OLP, although the exact mechanism is unknown.

Sulfasalazine is extensively used in inflammatory bowel disease and is effective on immune-related inflammatory disease such as Crohn's disease, rheumatoid arthritis, and Behcet's disease. In spite of its effectiveness, the anti-inflammatory mechanism is not clearly understood.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Oral Lichen Planus Corticosteroids Lichen Planus Lichen Planus, Oral Lichenoid Eruptions Mouth Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Stomatognathic Diseases Topical Sulfasalazine

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Dentistry, Cairo University

Cairo, 115, Egypt

About this study

  • Patients will be recruited in a consecutive manner from the outpatient Diagnostic center, Faculty of Dentistry, Cairo University.
  • A total number of 46 patients will be included in this study. The 23 patients categorized as study group (S group) will use topical sulfasalazine prepared by dissolving one tablet of commercially available (COLOSALAZINE - EC 500 MG 20 TAB, manufactured by: Alexandria Company for Pharmaceuticals & Chemical Industries, Alexandria) in 100 ml of distilled water 4 times per day as a mouth wash combined with topical corticosteroids 4 times per day as a topical gel in an alternate sequence. There are no expected side effects of this treatment due to its topical application however, the patient will be instructed to stop the treatment if any adverse reactions occur such as allergy and coming to the clinic next day.
  • The 23 patients categorized as control group (C group) will receive topical corticosteroids gel only 4 times per day. The treatment regimen will be continued for 4 weeks with follow up visits one per week.
  • Medical history will be taken, thorough oral examination will be done, and a full questionnaire will be filled for each patient.
  • All participants in the study groups will undergo adequate oral hygiene performance measures with complete removal of plaque and calculus as they implement intraoral inflammation and intensify both extension and symptoms of OLP lesions. Patients will be advised to evade accidental trauma on soft tissues using soft bristles toothbrush. Acidic, spicy, hard, hot food and beverages will be avoided.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - Patients with 30-65 years old
  • Patents with atrophic OLP

Exclusion criteria

  • - Smokers
  • pregnant or lactating ladies and
  • Patients under topical or systemic steroids during the last two months
  • Patients using lichenoid reaction-inducing drugs,
  • Patients with positive hepatitis C virus (HCV) antibodies, diabetes and hypertension
  • Patients having amalgam filling adjacent lesions will not also be included

Treatment and study plan

sulfasalazine 500 MG

Drug

The patients will use topical corticosteroids in addition to topical sulfasalazine 4 times per day.

Other names: colosalazine

Corticosteroids

Drug

The patients will use topical corticosteroids 4 times per day.

Other names: kenakort in orabase

Primary outcomes

  1. NAS

    Time frame: Every week for 4 weeks period

    Scale for pain assessment

  2. sign scoring scale of Thongprasom

    Time frame: Every week for 4 weeks period

    Score for severity

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Adjunctive Effect of Topical Sulfasalazine for Oral Lichen Planus Management: A Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 29, 2023
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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