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

Cairo University (CU)

Status and phase: Not yet enrolling; Phase 2

Conditions: Oral Lichen Planus

Treatments: Drug: 0.1% topical triamcinolone acetonide; Combination Product: Combination of Topical Bromelain and Triamcinolone Acetonide in Orabase; Dietary Supplement: Topical Bromelain

Study type: Interventional

Funder types: Other

Identifiers

NCT06981767

325

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 3 patient groups

Topical Bromelain in Orabase

Experimental group

Description:

Participants in this group will receive topical bromelain incorporated into an orabase. Patients will be instructed to apply the formulation four times daily No additional topical medications will be permitted.

Treatment:

Dietary Supplement: Topical Bromelain

Topical Triamcinolone Acetonide in Orabase

Active Comparator group

Description:

This group will receive topical 0.1% triamcinolone acetonide The treatment will be applied four times daily, following the same instructions and precautions as in Arm 1

Treatment:

Drug: 0.1% topical triamcinolone acetonide

Combination of Topical Bromelain and Triamcinolone Acetonide in Orabase

Experimental group

Description:

Participants in this arm will be treated with a combination formulation containing both topical bromelain and 0.1% triamcinolone acetonide in orabase. Application instructions will be identical to those in the other arms: four times daily.

Treatment:

Combination Product: Combination of Topical Bromelain and Triamcinolone Acetonide in Orabase