Recurrent Aphthous StomatitisPhase 2NCT06993337
Effect of Topical Bromelain Versus Topical Corticosteroids in the Management of Recurrent Aphthous Stomatitis
A Phase 2 study testing 35% Topical Bromelain in Orabase, 50% Topical Bromelain in Orabase and 0.1% Topical Triamcinolone Acetonide in Orabase in people with Recurrent Aphthous Stomatitis, run by Cairo University.
Trial summary
Bromelain, a natural product, exhibits anti-inflammatory, immunomodulatory, and wound-healing properties. However, its efficacy in treating oral mucosal ulcers remains unexplored. This study aims to evaluate the effect of bromelain as a safe alternate for management of RAS. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Recurrent Aphthous Stomatitis
- What is being tested?
- 35% Topical Bromelain in Orabase, 50% Topical Bromelain in Orabase and 0.1% Topical Triamcinolone Acetonide in Orabase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2025to 15 Jun 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-60 years.
- Diagnosed with RAS.
- Onset of ulcer within the last 48 hours.
- Willingness to participate and provide informed consent.
Who cannot join
- History of hematological deficiencies, GIT disorders, Behcet's disease and major systemic diseases.
- Pregnant or breastfeeding patients.
- Previous treatment for the current ulcer episode.
About this study
Official title: Evaluation of Topical Bromelain Versus Topical Corticosteroids in Management of Recurrent Aphthous Stomatitis: A Randomized Controlled Trial
Bromelain, a natural product, exhibits anti-inflammatory, immunomodulatory, and wound-healing properties. However, its efficacy in treating oral mucosal ulcers remains unexplored. This study aims to evaluate the effect of bromelain as a safe alternate for management of RAS.
- Conditions
- Recurrent Aphthous Stomatitis
- Being tested
- 35% Topical Bromelain in Orabase, 50% Topical Bromelain in Orabase, 0.1% Topical Triamcinolone Acetonide in Orabase
- Medical subject headings
- Stomatitis, Aphthous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
35% Topical Bromelain in OrabaseDietary supplement
Bromelain is a natural proteolytic enzyme derived from pineapple, recognized for its broad range of pharmacological properties. It exhibits significant anti-inflammatory effects by reducing edema. In addition to its anti-inflammatory activity, bromelain possesses antioxidant and analgesic properties.
50% Topical Bromelain in OrabaseDietary supplement
Bromelain is a natural proteolytic enzyme derived from pineapple, recognized for its broad range of pharmacological properties. It exhibits significant anti-inflammatory effects by reducing edema. In addition to its anti-inflammatory activity, bromelain possesses antioxidant and analgesic properties.
0.1% Topical Triamcinolone Acetonide in OrabaseDrug
Triamcinolone acetonide in orabase, a corticosteroid-based standard treatment for Recurrent Aphthous Stomatitis (RAS), is used for its strong anti-inflammatory and immunosuppressive effects. In this study, it serves as the conventional treatment against the novel therapy
| Study group | Role | What they receive |
|---|---|---|
| 35% Topical Bromelain in Orabase | Experimental | Participants in this group will receive 35% bromelain gel incorporated into an orabase adhesive medium. Receives: Dietary Supplement: 35% Topical Bromelain in Orabase |
| 50% Topical Bromelain in Orabase | Experimental | Participants assigned to this group will be treated with 50% bromelain gel formulated in orabase. Receives: Dietary Supplement: 50% Topical Bromelain in Orabase |
| 0.1% Topical Triamcinolone Acetonide in Orabase | Active comparator | This group will receive the standard treatment of 0.1% triamcinolone acetonide in orabase, commonly used for managing Recurrent Aphthous Stomatitis. Receives: Drug: 0.1% Topical Triamcinolone Acetonide in Orabase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain associated with ulcers
Pain reduction will be measured using a visual analog scale (VAS). VAS is a self-reported pain scores ranging from 0 to 10
Measured: Recorded at baseline, day 2, day 4 and day 7
Secondary outcomes (4)
Reduction in ulcer size
The reduction in ulcer size will be assessed using periodontal probe to measure dimensions in millimeters (mm)
Measured: Recorded at baseline, day 2, day 4 and day 7
Number of oral ulcers
Measured: Recorded at baseline, day 2, day 4 and day 7
Healing time of oral ulcer
The time to complete healing will be determined by the number of days until the ulcer is no longer visible upon clinical examination
Measured: Recorded at baseline, day 2, day 4 and day 7
Oral ulcer activity index
Oral ulcer activity index will be measured by Composite index (CI). CI score (0-10) is calculated by summing of subscale scores of oral ulcer activity (0 vs 1), oral ulcer-related pain status evaluated by categorized VAS (0-5) and the mean global functional disability score evaluated by 5-point Likert-type scale (0-4)
Measured: Recorded at baseline, day 2, day 4 and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start15 Jun 2025 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Aphthous StomatitisStudies 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
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Ahmed Ayoub Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993337
- Sponsor's protocol ID
- OMED 372
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 28 May 2025
- 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 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Topical Bromelain Versus Topical Corticosteroids in Management of Recurrent Aphthous Stomatitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06993337
- Acronym / sponsor ID
- OMED 372
- Conditions
- Recurrent Aphthous Stomatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 28 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, a natural product, exhibits anti-inflammatory, immunomodulatory, and wound-healing properties. However, its efficacy in treating oral mucosal ulcers remains unexplored. This study aims to evaluate the effect of bromelain as a safe alternate for management of RAS.
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 |
|---|---|---|
| 35% Topical Bromelain in Orabase | Experimental | Dietary Supplement: 35% Topical Bromelain in OrabaseParticipants in this group will receive 35% bromelain gel incorporated into an orabase adhesive medium. |
| 50% Topical Bromelain in Orabase | Experimental | Dietary Supplement: 50% Topical Bromelain in OrabaseParticipants assigned to this group will be treated with 50% bromelain gel formulated in orabase. |
| 0.1% Topical Triamcinolone Acetonide in Orabase | Active comparator | Drug: 0.1% Topical Triamcinolone Acetonide in OrabaseThis group will receive the standard treatment of 0.1% triamcinolone acetonide in orabase, commonly used for managing Recurrent Aphthous Stomatitis. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults aged 18-60 years.
- Diagnosed with RAS.
- Onset of ulcer within the last 48 hours.
- Willingness to participate and provide informed consent.
Key exclusion criteria (3 listed)
- History of hematological deficiencies, GIT disorders, Behcet's disease and major systemic diseases.
- Pregnant or breastfeeding patients.
- Previous treatment for the current ulcer episode.
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 |
|---|---|---|
| 35% Topical Bromelain in OrabaseBromelain is a natural proteolytic enzyme derived from pineapple, recognized for its broad range of pharmacological properties. It exhibits significant anti-inflammatory effects by reducing edema. In addition to its anti-inflammatory activity, bromelain possesses antioxidant and analgesic properties. | Dietary supplement | 35% Topical Bromelain in Orabase |
| 50% Topical Bromelain in OrabaseBromelain is a natural proteolytic enzyme derived from pineapple, recognized for its broad range of pharmacological properties. It exhibits significant anti-inflammatory effects by reducing edema. In addition to its anti-inflammatory activity, bromelain possesses antioxidant and analgesic properties. | Dietary supplement | 50% Topical Bromelain in Orabase |
| 0.1% Topical Triamcinolone Acetonide in OrabaseTriamcinolone acetonide in orabase, a corticosteroid-based standard treatment for Recurrent Aphthous Stomatitis (RAS), is used for its strong anti-inflammatory and immunosuppressive effects. In this study, it serves as the conventional treatment against the novel therapy | Drug | 0.1% Topical Triamcinolone Acetonide in Orabase |
Primary outcome
Pain associated with ulcers
Time frame: Recorded at baseline, day 2, day 4 and day 7
Pain reduction will be measured using a visual analog scale (VAS). VAS is a self-reported pain scores ranging from 0 to 10
4 secondary outcomes
Reduction in ulcer size
Time frame: Recorded at baseline, day 2, day 4 and day 7
Number of oral ulcers
Time frame: Recorded at baseline, day 2, day 4 and day 7
Healing time of oral ulcer
Time frame: Recorded at baseline, day 2, day 4 and day 7
Oral ulcer activity index
Time frame: Recorded at baseline, day 2, day 4 and day 7
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 28 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 35% Topical Bromelain in Orabase, 50% Topical Bromelain in Orabase and 0.1% Topical Triamcinolone Acetonide in Orabase in people with Recurrent Aphthous Stomatitis, run by Cairo University.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain associated with ulcers (time frame: Recorded at baseline, day 2, day 4 and day 7). 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 28 May 2025.