CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Epoetin 4000 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06923605
NCT06923605Phase 4Completed

The Efficacy of Erythropoietin Oral Gel Versus Erythropoietin Mouthwash in the Management of Recurrent Aphthous Stomatitis: A Randomized Controlled Clinical Study With Biochemical Analysis

Future University in Egypt·interventional·Posted Apr 11, 2025·Updated Aug 26, 2025

In Brief

A Phase 4 clinical trial evaluating Epoetin 4000 and Placebo for Recurrent Aphthous Stomatitis. Completed, enrolled 60 participants across 1 site.

Detailed 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. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

Phase 4CompletedFinished
20252026
First PostedApr 11, 2025
Enrollment StartJul 1, 2024
Primary CompletionDec 21, 2024
Study CompletionFeb 27, 2025
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 1.2 years ago

Interventions

Epoetin 4000drug

Erythropoietin hormone

Placeboother

isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl) 4 times daily