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

Phase 2

Not yet recruiting

• Conditions: Oral Lichen Planus
• Interventions: Dietary Supplement: Topical Bromelain; Drug: 0.1% topical triamcinolone acetonide; Combination Product: Combination of Topical Bromelain and Triamcinolone Acetonide in Orabase

• Registration Number: NCT06981767
• Lead Sponsor: Cairo University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-13
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21
• Study Start: 2025-06-15
• Primary Completion: 2026-05-15
• Study Completion: 2026-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical Bromelain in Orabase	Topical Bromelain	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 Triamcinolone Acetonide in Orabase	0.1% topical triamcinolone acetonide	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
Combination of Topical Bromelain and Triamcinolone Acetonide in Orabase	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.

Primary Outcome Measures

Name	Time	Method
Clinical improvement	Recorded at baseline, and weekly for 4 weeks	Clinical improvement will be measured using Thongprasom et al. scoring system. In Thongprasom et al. scale, lesions are given score as follows: 0, no lesions, normal mucosa; 1, Mild white striae, no erythematous area; 2, White striae with atrophic area \< 1 cm2; 3, White striae with atrophic area \> 1 cm2; 4, White striae with erosive area \< 1 cm2 and 5, White striae with erosive area \> 1 cm2 (Thongprasom et al., 2003).

Secondary Outcome Measures

Name	Time	Method
Pain intensity	baseline, daily for the first week, then weekly for the remaining 3 weeks.	Pain intensity will be measured using Visual analogue scale (VAS), VAS is a self-reported pain score ranging from 0 to 10 (Cheng et al., 2012) at baseline, daily for the first week, then weekly for the remaining 3 weeks.
Oral health-related quality of life	at baseline, and weekly for the 4 weeks.	Oral health-related quality of life using Oral Health Impact Profile-14 (OHIP-14) Oral health-related quality of life is a five-point Likert-type scale used in scoring each item of the OHIP-14. Responses are coded 0 = never', 1 = hardly ever', 2 = occasionally', 3 = fairly often', 4 = very often'. Item responses are summed to produce an OHIP-14 total score. Total OHIP-14 scores range from 0 (no impact) to 56 (all of the oral health problems are experienced very often). High scores indicates a poor oral health-related quality of life (Wiriyakijja et al., 2018).