Topical Sulfasalazine and Oral Lichen Planus

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Oral Lichen Planus; Corticosteroids; Topical Sulfasalazine
• Intervention / Treatment: Drug: sulfasalazine 500 MG; Drug: corticosteroids

Detailed Description

• 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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 115
    • Faculty of Dentistry, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group (S group); The patients will use topical sulfasalazine prepared by dissolving one tablet of commercially available 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.	Drug: sulfasalazine 500 MG; The patients will use topical corticosteroids in addition to topical sulfasalazine 4 times per day.; Other Names: colosalazine; Drug: corticosteroids; The patients will use topical corticosteroids 4 times per day.; Other Names: kenakort in orabase
Active Comparator: Control group (C group); 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.	Drug: corticosteroids; The patients will use topical corticosteroids 4 times per day.; Other Names: kenakort in orabase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NAS	Scale for pain assessment	Every week for 4 weeks period
sign scoring scale of Thongprasom	Score for severity	Every week for 4 weeks period

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Faculty O Dentistry, Cairo University, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 20, 2024

Study Registration Dates

• First Submitted: September 23, 2023
• First Submitted That Met QC Criteria: September 23, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

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; Anti-Infective Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Gastrointestinal Agents; Sulfasalazine
• Other Study ID Numbers: Faculty of Dentistry, Cairo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Because the research not published yet.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes