Effect of Topical Bromelain Versus Topical Corticosteroids in the Management of Oral Lichen Planus
NCT ID: NCT06981767
Last Updated: 2025-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
42 participants
INTERVENTIONAL
2025-06-15
2026-06-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Topical Bromelain in Orabase
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.
Topical 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.
Topical Triamcinolone Acetonide in Orabase
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
0.1% 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 of Topical Bromelain and Triamcinolone Acetonide in Orabase
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.
Combination 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.
Interventions
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Topical 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.
0.1% 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 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Lujain Taleb Suleiman Aladwan
Master's Student in Oral Medicine
Other Identifiers
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325
Identifier Type: -
Identifier Source: org_study_id
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