A Phase 4 interventional study of Epoetin 4000 and Placebo in Recurrent Aphthous Stomatitis, sponsored by Future University in Egypt. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-26.
Sponsored by Future University in Egypt · Phase 4, Interventional, and Treatment
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.
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.
63 studies on the registry are indexed under Stomatitis, Aphthous; 17 are open to participants now.
This study's enrollment of 60 is above the median of 41 across 54 interventional studies indexed under Stomatitis, Aphthous.
Browse Stomatitis, Aphthous studies →Future University in Egypt is the lead sponsor of 104 studies on the registry; 31 are open to participants now.
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Exclusion Criteria:
Patients with poor oral hygiene or not willing to perform oral hygiene measures.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
topical erythropoietin oral gel 4 times daily for 1 week
Drug: Epoetin 4000
isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl) 4 times daily
Other: Placebo
Erythropoietin mouthwash 4 times daily for 1 week
Drug: Epoetin 4000
Erythropoietin hormone
isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl) 4 times daily
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.
Time frame: Reduction from baseline and after 1 week of treatment
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.
Time frame: change from baseline and after 1 week of treatment
Biochemical analysis
Salivary IL-2 was detected by an Enzyme-Linked Immunosorbent Assay (ELISA). This sandwich kit is for the accurate quantitative detection of Human Interleukin 2 (also known as IL-2) in serum, plasma, cell culture supernates, Ascites, tissue homogenates or other biological fluids.
Time frame: From baseline and after 1 week of treatment
Plan to share: Yes — the age and number of the participants
Supporting information: Study protocol, Informed consent form
Time frame: will be available in September 2025
Access criteria: other researchers in oral medicine will be able to access, when the experiment is published internationally
Data sharing details ↗ · clinicaltrials.gov
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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