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NCT Number: NCT06981767

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cairo University

Cairo, Cairo Governorate, Egypt

Location status: Recruiting

Location contact

Lujain Taleb Aladwan, MSc

CONTACT

[email protected]

+201080837509

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

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.

Primary outcomes

  1. Clinical improvement

    Time frame: 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 outcomes

  1. Pain intensity

    Time frame: 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.

  2. Oral health-related quality of life

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Topical Bromelain Versus Topical Corticosteroids in the Management of Oral Lichen Planus : A Randomized Clinical Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 21, 2025
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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