Actively Recruiting

Phase 2
All Genders
ID06981767

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

All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Similar Trials

Evaluation of Efficacy and Safety of add-on Tofacitinib in P...

Oral Lichen Planus

Actively Recruiting

1 location

Efficacy of a Mucoadhesive Patch with Clobetasol and Resvera...

Oral Lichen Planus

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here