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Topical Sulfasalazine and Oral Lichen Planus

Sponsor
Cairo University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06060301
Collaborator
(none)
46
Enrollment
1
Location
2
Arms
8.7
Anticipated Duration (Months)
5.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Adjunctive Effect of Topical Sulfasalazine for Oral Lichen Planus Management: A Randomized Clinical Trial
Actual Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 20, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. NAS [Every week for 4 weeks period]

      Scale for pain assessment

    2. sign scoring scale of Thongprasom [Every week for 4 weeks period]

      Score for severity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Dentistry, Cairo University Cairo Egypt 115

    Sponsors and Collaborators

    • Cairo University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mai Zakaria Ibrahium Mohammed, Associate professor Oral Medicine & Periodontology, Cairo University
    ClinicalTrials.gov Identifier:
    NCT06060301
    Other Study ID Numbers:
    • Faculty of Dentistry, Cairo
    First Posted:
    Sep 29, 2023
    Last Update Posted:
    Sep 29, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Lichen Planus, Oral
    Lichen Planus
    Sulfasalazine

    Study Results

    No Results Posted as of Sep 29, 2023