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

NCT06981767 | Recruiting Phase 2 DMC

• 1 other identifier: 325
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Lichen Planus

Outcome Measures

Primary Outcomes (1)

• Clinical improvement

  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).

  Recorded at baseline, and weekly for 4 weeks

Secondary Outcomes (2)

• Pain intensity

  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.

Study Arms (3)

Topical Bromelain in Orabase

EXPERIMENTAL

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.

Dietary Supplement: Topical Bromelain

Topical Triamcinolone Acetonide in Orabase

ACTIVE COMPARATOR

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

Drug: 0.1% topical triamcinolone acetonide

Combination of Topical Bromelain and Triamcinolone Acetonide in Orabase

EXPERIMENTAL

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 Product: Combination of Topical Bromelain and Triamcinolone Acetonide in Orabase

Interventions

Topical Bromelain DIETARY_SUPPLEMENT

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 Bromelain in Orabase

Combination of Topical Bromelain and Triamcinolone Acetonide in Orabase COMBINATION_PRODUCT

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.

Combination of Topical Bromelain and Triamcinolone Acetonide in Orabase

0.1% topical triamcinolone acetonide DRUG

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

Topical Triamcinolone Acetonide in Orabase

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Bromelains; Triamcinolone Acetonide; Orabase

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cysteine Endopeptidases; Cysteine Proteases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Endopeptidases; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Student in Oral Medicine

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: February 18, 2026
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

EG (1)