The Efficacy of Erythropoietin Oral Gel Versus Erythropoietin Mouthwash in the Management of Recurrent Aphthous Stomatitis

NCT06923605 | Completed Phase 4 DMC

• 1 other identifier: FDAsu-Rec ID032209
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Aphthous Stomatitis

Keywords

Erythropoietin; IL-2; Recurrent aphthous stomatitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Reduction from baseline and after 1 week of treatment

Secondary Outcomes (1)

• Size of the ulcer

  change from baseline and after 1 week of treatment

Other Outcomes (1)

• Biochemical analysis

  From baseline and after 1 week of treatment

Study Arms (3)

Erythropoietin/oral gel

EXPERIMENTAL

topical erythropoietin oral gel 4 times daily for 1 week

Drug: Epoetin 4000

placebo

EXPERIMENTAL

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

Other: Placebo

Erythropoietin/mouthwash

EXPERIMENTAL

Erythropoietin mouthwash 4 times daily for 1 week

Drug: Epoetin 4000

Interventions

Epoetin 4000 DRUG

Erythropoietin hormone

Erythropoietin/mouthwash; Erythropoietin/oral gel

Placebo OTHER

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

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Future university in Egypt

New Cairo, Cairo Governorate, 4710001, Egypt

Location

Related Links

• Related Info

MeSH Terms

Conditions

Stomatitis, Aphthous

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Mai T. assistant lecturer Mai T. Elgendi, Assistant lecturer

  Faculty of oral medicine- Future University in Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturrer assistant

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: April 11, 2025
• Study Start: July 1, 2024
• Primary Completion: December 21, 2024
• Study Completion: February 27, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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

Locations

EG (1)