Actively Recruiting
Effect of Topical Bromelain Versus Topical Corticosteroids in the Management of Oral Lichen Planus: A Randomized Clinical Trial
Led by Cairo University · Updated on 2026-03-03
42
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying oral lichen planus (OLP), a condition causing painful oral mucosal ulcers, to evaluate the effectiveness of bromelain, an enzyme from pineapples known for its anti-inflammatory and wound-healing effects. This trial aims to provide clinical evidence on bromelain's potential as a safer and effective treatment option compared to traditional corticosteroids. It is a randomized, phase 2 clinical trial comparing different topical treatments for OLP. Participants are assigned to one of three groups: one group receives topical bromelain in orabase, another receives 0.1% topical triamcinolone acetonide in orabase (a corticosteroid), and the third group receives a combination of both bromelain and triamcinolone acetonide. All treatments are applied four times daily, and no additional topical medications are allowed during the study period. Participants will be monitored over four weeks with weekly assessments of clinical improvement. Pain intensity is tracked daily during the first week and then weekly for the remaining three weeks. Oral health-related quality of life is also evaluated at baseline and weekly. The study includes careful monitoring of symptoms and responses to treatment under triple masking conditions to ensure unbiased results.
CONDITIONS
Brief Title
Effect of Topical Bromelain Versus Topical Corticosteroids in the Management of Oral Lichen Planus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients suffering from symptomatic oral lichen planus (OLP)
- Patients free from any visible oral lesions other than OLP
- Patients who agree to take the supplied interventions
- Patients who agree to participate in the study
- Patients who will sign the informed consent
You will not qualify if you...
- Patients with any systemic disease
- Patients treated with systemic steroids, immunosuppressive drugs, or non-steroidal anti-inflammatory drugs within the last eight weeks
- Patients treated with any oral topical medications within the last four weeks
- Pregnant and lactating mothers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants apply topical treatment (bromelain, triamcinolone acetonide, or a combination) four times daily to manage oral lichen planus.
Weekly visits for 4 weeks
Trial Site Locations
Total: 1 location
1
Cairo University
Cairo, Cairo Governorate, Egypt
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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