Effect of Topical Bromelain Versus Topical Corticosteroids in the Management of Oral Lichen Planus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Topical Bromelain, 0.1% topical triamcinolone acetonide, Combination of Topical Bromelain and Triamcinolone Acetonide in Orabase.
- Who it may be relevant to
- Registry conditions: Oral Lichen Planus. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Topical Bromelain Versus Topical Corticosteroids in the Management of Oral Lichen Planus : A Randomized Clinical Trial
Overview
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.
Interventions
- Dietary supplement 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. - Drug 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 product 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.
Primary outcome measures
- Clinical improvement [Time frame: Recorded at baseline, and weekly for 4 weeks]
Secondary outcome measures (2)
- Pain intensity [Time frame: baseline, daily for the first week, then weekly for the remaining 3 weeks.]
- Oral health-related quality of life [Time frame: at baseline, and weekly for the 4 weeks.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Cairo University — Cairo
Identifiers
NCT: NCT06981767 · 325