Oral Lichen PlanusPhase 3NCT06060301
Topical Sulfasalazine and Oral Lichen Planus
A Phase 3 study testing sulfasalazine 500 MG and corticosteroids in people with Oral Lichen Planus and Topical Sulfasalazine, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Oral Lichen Planus, Topical Sulfasalazine, Corticosteroids
- What is being tested?
- sulfasalazine 500 MG and corticosteroids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 20 Oct 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Patients with 30-65 years old
- Patents with atrophic OLP
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Oral Lichen Planus, Topical Sulfasalazine, Corticosteroids
- Being tested
- sulfasalazine 500 MG, corticosteroids
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sulfasalazine 500 MGDrug
Also called colosalazine
The patients will use topical corticosteroids in addition to topical sulfasalazine 4 times per day.
corticosteroidsDrug
Also called kenakort in orabase
The patients will use topical corticosteroids 4 times per day.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
NAS
Scale for pain assessment
Measured: Every week for 4 weeks period
sign scoring scale of Thongprasom
Score for severity
Measured: Every week for 4 weeks period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Mar 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion20 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Zakaria Ibrahium Mohammed, Cairo University
- Investigators
- Faculty O Dentistry, Cairo University, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060301
- Sponsor's protocol ID
- Faculty of Dentistry, Cairo
- Status last verified
- Jul 2024
- First submitted
- 23 Sep 2023
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because the research not published yet.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Effect of Topical Sulfasalazine for Oral Lichen Planus Management: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06060301
- Acronym / sponsor ID
- Faculty of Dentistry, Cairo
- Conditions
- Oral Lichen Planus, Topical Sulfasalazine, Corticosteroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 20 Oct 2024 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group (S group) | Experimental | Drug: sulfasalazine 500 MG, Drug: corticosteroidsThe 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. |
| Control group (C group) | Active comparator | Drug: corticosteroidsThe 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- - Patients with 30-65 years old
- Patents with atrophic OLP
Key exclusion criteria (6 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sulfasalazine 500 MGAlso: colosalazineThe patients will use topical corticosteroids in addition to topical sulfasalazine 4 times per day. | Drug | study group (S group) |
| corticosteroidsAlso: kenakort in orabaseThe patients will use topical corticosteroids 4 times per day. | Drug | Control group (C group), study group (S group) |
Primary outcome
NAS
Time frame: Every week for 4 weeks period
Scale for pain assessment
sign scoring scale of Thongprasom
Time frame: Every week for 4 weeks period
Score for severity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: No. Because the research not published yet.
Related trials for Oral Lichen Planus
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Not yet recruiting
Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
Oral Lichen Planus
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Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
Degree of Adherence of Symptomatic OLP Patients to Their Medications
Active, not recruitingPhase 4
Low Level Laser Therapy With Injectable Platelet Rich Fibrin in Management of Oral Lichen Planus
Oral Lichen Planus
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Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Erythroplakia, Fanconi Anemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faculty O Dentistry, Cairo University study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sulfasalazine 500 MG and corticosteroids in people with Oral Lichen Planus and Topical Sulfasalazine, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NAS (time frame: Every week for 4 weeks period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.