Recurrent Aphthous StomatitisPhase 4NCT06923605
The Efficacy of Erythropoietin Oral Gel Versus Erythropoietin Mouthwash in the Management of Recurrent Aphthous Stomatitis
A Phase 4 study testing Epoetin 4000 in people with Recurrent Aphthous Stomatitis, run by Future University in Egypt at 1 site in Egypt.
Trial summary
Erythropoietin (EPO) exerts anti-inflammatory effects by inhibiting NF- kappa B-dependent formation of pro-inflammatory cytokines, thus it reduces local and circulating levels of these disease (recurrent aphthous stomatitis RAS) related cytokines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Aphthous Stomatitis
- What is being tested?
- Epoetin 4000
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 27 Feb 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients should be free from any systemic disease or Behcet syndrome.
- Patients ≥18 years of age, male or female are eligible.
- Oral pain score of 4 or higher on a scale of 0-10 with 0 representing no pain in the presence of oral ulceration.
- Patient has only aphthous ulcer and It should had not been passed more than 4 days from beginning of their ulcer.
Who cannot join
- • Patients with poor oral hygiene or not willing to perform oral hygiene measures.
- Smoking and alcohol use.
- Pregnant and lactating females
- Patients with history of any topical or systemic medication or steroid therapy 1 month prior to the investigation.
- The vulnerable group; prisoners, mentally or physically disabled patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Erythropoietin Oral Gel Versus Erythropoietin Mouthwash in the Management of Recurrent Aphthous Stomatitis: A Randomized Controlled Clinical Study With Biochemical Analysis
Erythropoietin (EPO) exerts anti-inflammatory effects by inhibiting NF- kappa B-dependent formation of pro-inflammatory cytokines, thus it reduces local and circulating levels of these disease (recurrent aphthous stomatitis RAS) related cytokines. So, it is considered as a potent anti-inflammatory cytokine in inflammatory disorders and infectious disease. It also accelerates wound-healing and decreases the extent of apoptosis and the areas of the open wound. this drug seems to be a promising therapeutic option in oral lesions. the effectiveness of EPO oral gel and EPO mouth wash were compared on patients with recurrent aphthous stomatitis and investigated therapeutic mechanism by examining treatment effect on expression of IL-2 IN RAS.
Read the detailed description
Sixty patients with recurrent aphthous stomatitis were randomly assigned into three equal groups to receive topical Erythropoietin oral gel four times per day (after meals and at bedtime) (Group I).
Erythropoietin mouthwash 4 times per day (after meals and at bedtime) (Group II), and placebo isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl) (Group III).
All patients were followed up four 1 week, photographs were taken at the beginning and end of the treatment.
patients were assessed using pain visual analogue scale (PVAS), clinical assessments for the size of the ulcers and rate of their recurrence.
pretreatment and post treatment salivary samples were taken to detect the expression and levels of salivary IL-2.
- Conditions
- Recurrent Aphthous Stomatitis
- Being tested
- Epoetin 4000, Placebo
- Keywords
- Erythropoietin, IL-2, Recurrent aphthous stomatitis
- Medical subject headings
- Stomatitis, Aphthous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin 4000Drug
Erythropoietin hormone
PlaceboOther
isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl) 4 times daily
| Study group | Role | What they receive |
|---|---|---|
| Erythropoietin/oral gel | Experimental | topical erythropoietin oral gel 4 times daily for 1 week Receives: Drug: Epoetin 4000 |
| placebo | Experimental | isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl) 4 times daily Receives: Other: Placebo |
| Erythropoietin/mouthwash | Experimental | Erythropoietin mouthwash 4 times daily for 1 week Receives: Drug: Epoetin 4000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain visual analogue scale (P-VAS)
The pain VAS consisted of a 10-cm horizontal line marked 0-10 (0 no pain, 10 most severe pain experienced). Patients marked the scale at each visit, and the all P-VAS were included on one sheet of paper allowing the patient to think in terms of change instead of absolutes. The P-VAS was then scored by measuring from the patient's mark to the beginning of the scale in cm.
Measured: Reduction from baseline and after 1 week of treatment
Secondary outcomes (1)
Size of the ulcer
The score corresponds to the average diameter of the ulcers in millimeters, that is, a patient having ulcers of average size of 5 mm would score 5. Patients indicated the average size of their ulcers on a diagram of different diameter circles. The maximum score was 20 to accommodate the small number of RAS cases in which ulcers are on average more than 10 mm in diameter.
Measured: change from baseline and after 1 week of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start1 Jul 2024
- Primary completion21 Dec 2024
- Study completion27 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Aphthous StomatitisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Talaat Mohamed, Future University in Egypt
- Investigators
- Mai T. assistant lecturer Mai T. Elgendi, Assistant lecturer, Study director, Faculty of oral medicine- Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923605
- Sponsor's protocol ID
- FDAsu-Rec ID032209
- Status last verified
- Aug 2025
- First submitted
- 11 Mar 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the age and number of the participants
Publications
Elgendi MT, Hussein RR, Ragy N, El Hoffy NM, El Din NHK. Efficacy of topical erythropoietin gel and mouthwash for recurrent aphthous stomatitis in a randomized clinical trial. Sci Rep. 2026 Mar 18;16(1):9339. doi: 10.1038/s41598-026-40440-7.
PubMed 41851196
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Erythropoietin Oral Gel Versus Erythropoietin Mouthwash in the Management of Recurrent Aphthous Stomatitis: A Randomized Controlled Clinical Study With Biochemical Analysis
- ClinicalTrials.gov ID
- NCT06923605
- Acronym / sponsor ID
- FDAsu-Rec ID032209
- Conditions
- Recurrent Aphthous Stomatitis
- Keywords
- Erythropoietin, IL-2, Recurrent aphthous stomatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 21 Dec 2024 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 11 Apr 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.
Erythropoietin (EPO) exerts anti-inflammatory effects by inhibiting NF- kappa B-dependent formation of pro-inflammatory cytokines, thus it reduces local and circulating levels of these disease (recurrent aphthous stomatitis RAS) related cytokines. So, it is considered as a potent anti-inflammatory cytokine in inflammatory disorders and infectious disease. It also accelerates wound-healing and decreases the extent of apoptosis and the areas of the open wound. this drug seems to be a promising therapeutic option in oral lesions. the effectiveness of EPO oral gel and EPO mouth wash were compared on patients with recurrent aphthous stomatitis and investigated therapeutic mechanism by examining treatment effect on expression of IL-2 IN RAS.
Detailed description
Sixty patients with recurrent aphthous stomatitis were randomly assigned into three equal groups to receive topical Erythropoietin oral gel four times per day (after meals and at bedtime) (Group I).
Erythropoietin mouthwash 4 times per day (after meals and at bedtime) (Group II), and placebo isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl) (Group III).
All patients were followed up four 1 week, photographs were taken at the beginning and end of the treatment.
patients were assessed using pain visual analogue scale (PVAS), clinical assessments for the size of the ulcers and rate of their recurrence.
pretreatment and post treatment salivary samples were taken to detect the expression and levels of salivary IL-2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Erythropoietin/oral gel | Experimental | Drug: Epoetin 4000topical erythropoietin oral gel 4 times daily for 1 week |
| placebo | Experimental | Other: Placeboisotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl) 4 times daily |
| Erythropoietin/mouthwash | Experimental | Drug: Epoetin 4000Erythropoietin mouthwash 4 times daily for 1 week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients should be free from any systemic disease or Behcet syndrome.
- Patients ≥18 years of age, male or female are eligible.
- Oral pain score of 4 or higher on a scale of 0-10 with 0 representing no pain in the presence of oral ulceration.
- Patient has only aphthous ulcer and It should had not been passed more than 4 days from beginning of their ulcer.
Key exclusion criteria (5 listed)
- • Patients with poor oral hygiene or not willing to perform oral hygiene measures.
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 |
|---|---|---|
| Epoetin 4000Erythropoietin hormone | Drug | Erythropoietin/mouthwash, Erythropoietin/oral gel |
| Placeboisotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl) 4 times daily | Other | placebo |
Primary outcome
Pain visual analogue scale (P-VAS)
Time frame: Reduction from baseline and after 1 week of treatment
The pain VAS consisted of a 10-cm horizontal line marked 0-10 (0 no pain, 10 most severe pain experienced). Patients marked the scale at each visit, and the all P-VAS were included on one sheet of paper allowing the patient to think in terms of change instead of absolutes. The P-VAS was then scored by measuring from the patient's mark to the beginning of the scale in cm.
1 secondary outcome
Size of the ulcer
Time frame: change from baseline and after 1 week of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Derived from this study: PubMed 41851196Elgendi MT, Hussein RR, Ragy N, El Hoffy NM, El Din NHK. Efficacy of topical erythropoietin gel and mouthwash for recurrent aphthous stomatitis in a randomized clinical trial. Sci Rep. 2026 Mar 18;16(1):9339. doi: 10.1038/s41598-026-40440-7.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. the age and number of the participants
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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. This study is not recruiting at the moment.
Mai T. assistant lecturer Mai T. Elgendi, Assistant lecturer study director
Faculty of oral medicine- Future University in Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epoetin 4000 in people with Recurrent Aphthous Stomatitis, run by Future University in Egypt 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 26 Aug 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 visual analogue scale (P-VAS) (time frame: Reduction from baseline and after 1 week of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06923605, which also lists 1 linked publication.
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 26 Aug 2025.