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Topical Sulfasalazine and Oral Lichen Planus

Primary Purpose

Oral Lichen Planus, Topical Sulfasalazine, Corticosteroids

Status
Active
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
sulfasalazine 500 MG
corticosteroids
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Lichen Planus

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Dentistry, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

study group (S group)

Control group (C group)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

NAS
Scale for pain assessment
sign scoring scale of Thongprasom
Score for severity

Secondary Outcome Measures

Full Information

First Posted
September 23, 2023
Last Updated
September 23, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT06060301
Brief Title
Topical Sulfasalazine and Oral Lichen Planus
Official Title
Adjunctive Effect of Topical Sulfasalazine for Oral Lichen Planus Management: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Lichen Planus, Topical Sulfasalazine, Corticosteroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group (S group)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group (C group)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
sulfasalazine 500 MG
Other Intervention Name(s)
colosalazine
Intervention Description
The patients will use topical corticosteroids in addition to topical sulfasalazine 4 times per day.
Intervention Type
Drug
Intervention Name(s)
corticosteroids
Other Intervention Name(s)
kenakort in orabase
Intervention Description
The patients will use topical corticosteroids 4 times per day.
Primary Outcome Measure Information:
Title
NAS
Description
Scale for pain assessment
Time Frame
Every week for 4 weeks period
Title
sign scoring scale of Thongprasom
Description
Score for severity
Time Frame
Every week for 4 weeks period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faculty O Dentistry, Cairo University
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Dentistry, Cairo University
City
Cairo
ZIP/Postal Code
115
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Because the research not published yet.

Learn more about this trial

Topical Sulfasalazine and Oral Lichen Planus

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