Topical bromelain versus topical corticosteroid for oral lichen planus
Effect of Topical Bromelain Versus Topical Corticosteroids in the Management of Oral Lichen Planus : A Randomized Clinical Trial
This trial will test whether a pineapple-derived enzyme gel (bromelain), alone or combined with a topical steroid, helps people with symptomatic oral lichen planus heal and have less pain.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Trial ID | NCT06981767 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial compares three topical regimens for symptomatic oral lichen planus: 0.1% triamcinolone acetonide in Orabase, topical bromelain, and a combination of bromelain plus triamcinolone in Orabase. Eligible participants without other oral lesions or recent systemic/topical immunosuppressive treatment will receive one of the three preparations and be followed for lesion healing, pain/symptom changes, and local adverse effects. Treatments are applied to the oral mucosa and clinical response and safety will be recorded over the treatment period. The goal is to determine whether bromelain alone or as an adjunct can provide effective, well-tolerated topical therapy compared with the standard steroid preparation.
Who should consider this trial
Good fit: Ideal candidates are adults with symptomatic oral lichen planus who have no other visible oral lesions, are not pregnant or lactating, and have not used systemic or topical immunosuppressive treatments within the required washout periods.
Not a fit: Patients with concurrent systemic disease, ongoing systemic immunosuppression, recent topical treatments, or who are pregnant or lactating are unlikely to be eligible and may not benefit from participation.
Why it matters
Potential benefit: If successful, this could provide a safer or steroid-sparing topical option to reduce pain and speed healing in people with oral lichen planus.
How similar studies have performed: Topical corticosteroids like triamcinolone are an established effective treatment for OLP, while topical bromelain for oral mucosal lesions is novel and has limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients suffering from symptomatic OLP * Patients free from any visible oral lesions other than OLP. * Patients who agreed to take the supplied interventions. * Patient who will agree to participate in the study. * Patients who will accept to sign the informed consent. Exclusion Criteria: * Patients suffering from any systemic disease. * Treatment with any systemic treatment such as systemic steroids, other immunosuppressive drugs or non-steroidal anti-inflammatory drugs at least eight weeks. * Treatment with any oral topical medications for at least four weeks prior to the study. * Pregnant and lactating mothers.
Where this trial is running
Cairo, Cairo Governorate
- Cairo University — Cairo, Cairo Governorate, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.