RecruitingPhase 2NCT06981767

Effect of Topical Bromelain Versus Topical Corticosteroids in the Management of Oral Lichen Planus

Effect of Topical Bromelain Versus Topical Corticosteroids in the Management of Oral Lichen Planus : A Randomized Clinical Trial


Sponsor

Cairo University

Enrollment

42 participants

Start Date

Feb 18, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Bromelain, an enzyme extract derived from pineapples, has shown promise due to its anti-inflammatory and wound-healing properties. However, its efficacy in treating oral mucosal ulcers remains unexplored. This study aims to provide clinical evidence on the efficacy of bromelain for managing OLP, potentially offering a safer and more effective treatment option.


Eligibility

Inclusion Criteria5

  • 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 Criteria4

  • 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.

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Interventions

DIETARY_SUPPLEMENTTopical Bromelain

A natural enzyme-based formulation derived from pineapple, bromelain in orabase is being investigated for its anti-inflammatory and wound-healing properties. As a non-steroidal alternative, it offers a potentially safer treatment option with minimal side effects.

DRUG0.1% topical triamcinolone acetonide

A corticosteroid-based standard treatment for OLP, triamcinolone acetonide in orabase is used for its strong anti-inflammatory and immunosuppressive effects. It serves as the conventional treatment versus novel therapy in this study

COMBINATION_PRODUCTCombination of Topical Bromelain and Triamcinolone Acetonide in Orabase

This novel formulation combines the enzymatic, healing properties of bromelain with the anti-inflammatory property of triamcinolone. It is designed to provide enhanced therapeutic effects through synergistic action, potentially reducing the required corticosteroid dose while improving clinical outcomes.


Locations(1)

Cairo University

Cairo, Cairo Governorate, Egypt

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NCT06981767


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