Oral Lichen PlanusPhase 2NCT06981767
Effect of Topical Bromelain Versus Topical Corticosteroids in the Management of Oral Lichen Planus
A Phase 2 study testing Topical Bromelain, 0.1% topical triamcinolone acetonide and Combination of Topical Bromelain and Triamcinolone Acetonide in Orabase in people with Oral Lichen Planus, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Topical Bromelain, 0.1% topical triamcinolone acetonide and Combination of Topical Bromelain and Triamcinolone Acetonide in Orabase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Feb 2026to 15 Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, Cairo Governorate
Lujain Taleb Aladwan, MSc, +201080837509, lujain.aladwan@dentistry.cu.edu.eg
About this study
Official title: Effect of Topical Bromelain Versus Topical Corticosteroids in the Management of Oral Lichen Planus : A Randomized Clinical Trial
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
- Being tested
- Topical Bromelain, 0.1% topical triamcinolone acetonide, Combination of Topical Bromelain and Triamcinolone Acetonide in Orabase
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical BromelainDietary 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 acetonideDrug
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 OrabaseCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Combination Product: Combination of Topical Bromelain and Triamcinolone Acetonide in Orabase |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Recorded at baseline, and weekly for 4 weeks
Secondary outcomes (2)
Pain intensity
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.
Measured: baseline, daily for the first week, then weekly for the remaining 3 weeks.
Oral health-related quality of life
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).
Measured: at baseline, and weekly for the 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start18 Feb 2026
- Primary completion20 Jul 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lujain Taleb Suleiman Aladwan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981767
- Sponsor's protocol ID
- 325
- Status last verified
- Feb 2026
- First submitted
- 13 May 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Bromelain Versus Topical Corticosteroids in the Management of Oral Lichen Planus : A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06981767
- Acronym / sponsor ID
- 325
- Conditions
- Oral Lichen Planus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- 20 Jul 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Topical Bromelain in Orabase | Experimental | Dietary Supplement: Topical BromelainParticipants 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 | Active comparator | Drug: 0.1% topical triamcinolone acetonideThis 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 | Experimental | Combination Product: Combination of Topical Bromelain and Triamcinolone Acetonide in OrabaseParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical BromelainA 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. | Dietary supplement | Topical Bromelain in Orabase |
| 0.1% topical triamcinolone acetonideA 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 | Drug | Topical Triamcinolone Acetonide in Orabase |
| Combination of Topical Bromelain and Triamcinolone Acetonide in OrabaseThis 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 product | Combination of Topical Bromelain and Triamcinolone Acetonide in Orabase |
Primary outcome
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).
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
Related trials for Oral Lichen Planus
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Not yet recruiting
Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
Oral Lichen Planus
Not yet recruiting
Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
Degree of Adherence of Symptomatic OLP Patients to Their Medications
Active, not recruitingPhase 4
Low Level Laser Therapy With Injectable Platelet Rich Fibrin in Management of Oral Lichen Planus
Oral Lichen Planus
Active, not recruiting
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Erythroplakia, Fanconi Anemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topical Bromelain, 0.1% topical triamcinolone acetonide and Combination of Topical Bromelain and Triamcinolone Acetonide in Orabase in people with Oral Lichen Planus, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement (time frame: Recorded at baseline, and weekly for 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.