Topical Sulfasalazine and Oral Lichen Planus

NCT06060301 | Active Not Recruiting Phase 3

• 1 other identifier: Faculty of Dentistry, Cairo
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Lichen Planus; Topical Sulfasalazine; Corticosteroids

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

study group (S group)

EXPERIMENTAL

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; Drug: corticosteroids

Control group (C group)

ACTIVE COMPARATOR

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

Interventions

sulfasalazine 500 MG DRUG

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

Also known as: colosalazine

study group (S group)

corticosteroids DRUG

The patients will use topical corticosteroids 4 times per day.

Also known as: kenakort in orabase

Control group (C group); study group (S group)

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, 115, Egypt

Location

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Sulfasalazine; Adrenal Cortex Hormones; Orabase

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Faculty O Dentistry, Cairo University

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor Oral Medicine & Periodontology

Study Record Dates

• First Submitted: September 23, 2023
• First Posted: September 29, 2023
• Study Start: March 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: October 20, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)